Remote Acute Assessment of Patients With High Cardiovascular Risk Post-Acute Coronary Syndrome
Phase: NA
Conditions: Cardiovascular Diseases, Acute Coronary Syndrome
Sponsor: Imperial College London

 
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Template Protocol for non-CTIMPs 
TELE-ACS 
 
 
 
 
Remote Acute Assessment of Patients with High Cardiovascular Risk 
Post-Acute Coronary Syndrome 
 
 
 
 
Version 1.1 
1st December 2021 
 
 
 
 
MAIN SPONSOR: Imperial College London 
FUNDERS: King Khalid University via The Saudi Arabian Cultural Bureau.  
STUDY COORDINATION CENTRE: NHLI, Imperial College London  
 
IRAS Project ID: 291565 
REC reference: 21/LO/0651 
 
 
 
 
Protocol authorised by: 
 
Name & Role 
Date 
Signature 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Study Management Group 
 
Chief Investigator:  
Dr Ramzi Khamis 
 
Co-investigators: 
 
Mr Nasser S Alshahrani 
Prof Nicholas Peters 
Dr Adam Hartley 
Dr James Howard 
Dr Rasha Al-Lamee 
Dr Amit Kaura 
Dr Mihir Kelshiker 
Dr Saud Khawaja 
Dr Henry Seligman 
Dr Tamim Akbari 
 
Statistician:  
 
Mr. Paul Bassett 
 
Study Management:  
 
Mr Nasser S Alshahrani 
 
Study Coordination Centre  
 
National Heart and Lung Institute, Imperial College London 
Hammersmith Hospital, Imperial College Healthcare NHS Trust 
 
For general queries, supply of study documentation, and collection of data, please 
contact: 
 
Study Coordinator: Nasser Alshahrani 
Address: National Heart and Lung Institute, Imperial Centre for Translational and 
Experimental Research, Hammersmith Campus, Du Cane Road, W12 0NN 
 
 
E-mail:  n.alshahrani20@imperial.ac.uk 
 
 
 
 
 
 
 
 
Clinical and Study Queries 
 
Clinical and specific study queries should be directed to the research team via email and 
phone:   
Email: n.alshahrani20@imperial.ac.uk 
Mobile: 07496861415 - 07733344588 
 

 
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Sponsor 
 
Imperial College London is the main research Sponsor for this study.  For further 
information regarding the sponsorship conditions, please contact the Head of 
Research Governance and Integrity at: 
 
 
 
Research Governance and Integrity Team 
Imperial College London and Imperial College Healthcare NHS Trust 
Room 215, Level 2, Medical School Building 
Norfolk Place 
London, W2 1PG 
Tel: 0207 594 9459/ 0207 594 1862 
https://www.imperial.ac.uk/research-and-innovation/research-office/research-
governance-and-integrity/  
 
 

 
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Funder 
 
King Khalid University  
 
The Saudi Arabian Cultural Bureau in the UK will serve to act as a liaison between King 
Khalid University and Imperial College London relates to scholarship matters. 
 
This protocol describes the TELE-ACS study and provides information about procedures for 
entering participants.  Every care was taken in its drafting, but corrections or amendments may 
be necessary. These will be circulated to investigators in the study.  Problems relating to this 
study should be referred, in the first instance, to the Chief Investigator.  
 
This study will adhere to the principles outlined in the UK Policy Frame Work for Health and 
Social Care Research. It will be conducted in compliance with the protocol, the Data Protection 
Act and other regulatory requirements as appropriate.  
 
Table of Contents                                                             Page No 
1. 
INTRODUCTION 
8 
1.1. 
BACKGROUND 
8 
1.2. 
RATIONALE FOR CURRENT STUDY 
8 
2. 
STUDY OBJECTIVES 
9 
3. 
STUDY DESIGN 
9 
3.1. 
STUDY OUTCOME MEASURES 
11 
4. 
PARTICIPANT ENTRY 
12 
4.1. 
PRE-REGISTRATION EVALUATIONS 
12 
4.2. 
INCLUSION CRITERIA 
12 
4.3. 
EXCLUSION CRITERIA 
12 
4.4. 
WITHDRAWAL CRITERIA 
12 
5. 
ADVERSE EVENTS 
12 
5.1. 
DEFINITIONS 
12 
5.2. 
REPORTING PROCEDURES 
13 
6. 
ASSESSMENT AND FOLLOW-UP 
14 
7. 
STATISTICS AND DATA ANALYSIS 
14 
8. 
REGULATORY ISSUES 
15 
8.1. 
ETHICS APPROVAL 
15 
8.2. 
CONSENT 
15 
8.3. 
CONFIDENTIALITY 
15 
8.4. 
INDEMNITY 
15 
8.5. 
SPONSOR 
15 
8.6. 
FUNDING 
15 
8.7. 
AUDITS 
15 
9. 
STUDY MANAGEMENT 
15 
10. 
PUBLICATION POLICY 
16 
11. 
REFERENCES 
17 
12.      EXAMPLES APPENDICES                                                                             18 
 
 

 
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GLOSSARY OF ABBREVIATIONS 
ACS 
Acute coronary syndrome 
A&E 
Accident and emergency 
BP 
Blood pressure 
ECG 
Electrocardiogram 
HAC 
Heart assessment centre 
HF 
Heart failure  
hsTnI 
High sensitivity troponin I 
MI 
Myocardial infarction 
NSTEMI 
Non-ST-segment elevation myocardial infarction 
PCI 
Percutaneous coronary intervention 
STEMI 
ST-segment elevation myocardial infarction. 
TELE 
Telemedicine 
TC  
Trial Coordinator 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
KEYWORDS 
Myocardial infarction, Acute coronary syndrome, Telemedicine 
 
 
 
 
 
 
 
 

 
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STUDY SUMMARY 
 
TITLE 
Remote Acute Assessment of Patients with High Cardiovascular Risk Post-Acute 
Coronary Syndrome 
DESIGN 
Randomised Controlled Trial 
AIMS 
1- Ensuring that patients present appropriately even though there is an inherent risk 
to attend post-myocardial infarction. 
2- To prevent unnecessary presentations, as assessed by well-validated 
technologies coupled with an urgent remote consultation with a specialist.  
OUTCOME 
MEASURES 
Primary:  All hospital readmission rates (formal admissions and not emergency 
room visits) at 6 months of follow up in intervention vs control groups. 
Secondary: Total length of stay, All-cause mortality, morbidity, and MACE, Medical 
intervention for acute coronary syndromes or heart failure, Emergency Room visits 
not requiring admission or further intervention, 9 months readmission rates, and 
Patient-reported quality of life outcome measures 
POPULATION 
The patient population will comprise the most vulnerable patients to further 
myocardial infarction 
ELIGIBILITY 
ACS Patients diagnosed with elevated high-sensitivity troponin I who have 
undergone coronary intervention for non-ST-segment acute coronary syndrome 
(NSTE-ACS) or ST-segment elevation myocardial infarction (STEMI) or unstable 
angina (UA). The patients must have at least one additional cardiovascular risk 
factors.  
DURATION 
9 Months  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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REFERENCE DIAGRAM 
 
Abbreviations: ACS, acute coronary syndrome; A&E, accident and emergency; BP, blood 
pressure; ECG; electrocardiogram; HAC, heart assessment centre; hsTnI, high sensitivity 
troponin I; NSTEMI, non-ST-segment elevation myocardial infarction; PCI, percutaneous 

 
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coronary intervention; STEMI, ST-segment elevation myocardial infarction; TC, Trial 
Coordinator.  
  
1. INTRODUCTION  
 
1.1. 
BACKGROUND 
Myocardial infarction remains one of the leading causes of mortality in the UK, despite cutting 
edge medical and interventional therapy. As length of stay in hospital for myocardial infarction 
decreases in line with global trends, UK unplanned re-admission rates remain high at about 
10% at 30-days (1). This is representative of global data, with a recent meta-analysis reporting 
30-day readmission rates of between 11-14%, and are even higher in the USA (2). Table 1 
shows several studies have previously analysed the readmissions rates for patients with Acute 
Coronary Syndrome (ACS) within 30-day, 3-month and 1-year. The readmission rate of 61.7% 
reported in the study by Southern et al., who evaluated the rate of readmissions in 3,411 
patients within 1-year after first admission for ACS in Canada, even though 34.1% readmitted 
within 30-day as inpatient and 27.6% emergency department only (3). A study conducted in 
the USA reported women of all ages have a higher risk of readmission compared with men at 
1-year after AMI and the readmission rate was 24.5% (Figure 1) (4). These readmissions are 
for both cardiovascular causes (such as further myocardial infarction, anginal chest pain or 
heart failure) as well as non-cardiovascular causes, most prominently non-cardiac chest pain, 
in up to 50% (1). Regardless, the mortality in patients 30-days post-discharge for acute 
myocardial infarction is 7.3% with little change over time (5). Indeed the most current UK data 
of 30-day mortality in those undergoing coronary intervention for acute coronary syndromes 
varies between 1.6-43.1%, depending on the presence of ST-segment elevation and shock at 
presentation (6). 
 
1.2. 
RATIONALE FOR CURRENT STUDY 
The utilisation of telemedicine devices has the potential to provide remote, clinically 
necessary, diagnostic information, without the need for hospital attendance. One such device 
is the smartheartTM (SHL Telemedicine), which is a CE/ FDA-approved personal mobile 12-
lead ECG device, that produces and transmits hospital-grade electrocardiograms (ECGs) 
within 30 seconds, via Bluetooth and cellular communication. Indeed, use of SHL 
Telemedicine devices along with their bespoke call centre and mobile intensive care unit has 
previously been demonstrated to reduce post-acute myocardial infarction readmission rates 
to 5.3% in a retrospective study (7). 
 
Emergency presentation with acute coronary syndromes has significantly reduced during the 
COVID-19 pandemic globally, and specifically in the UK (8, 9). There are multiple explanations 
for this, including perceived increased health risks of hospital attendance, as well as a 
reluctance to seek medical attention in order to limit the burden on the healthcare system. This 
is likely to have significant short-term and long-term health sequalae. Out-of-hospital cardiac 
arrests have transiently doubled in frequency over the course of the lockdown, in line with 
reduced survival (10, 11). This is likely attributable to the effects of the virus itself, as well as 
reluctance to seek medical attention and adjustment of healthcare services. Expected long-
term consequences of reduced emergency department attendance for acute coronary 

 
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syndromes will include an increase in ischaemic cardiomyopathy, heart failure and mortality. 
Similar patterns of acute cardiac care service usage were expected if a second surge of 
COVID-19 were to occur. Thus, there is a clear mandate to reduce unnecessary hospital 
readmissions, increase and encourage appropriate emergency attendance and reduce 
mortality rates in patients following acute myocardial infarction. 
 
 
 
2. STUDY OBJECTIVES 
 
The study objective is to determine the effect of utilising telemedicine devices to provide 
remote, clinically necessary, diagnostic information, without the need for hospital attendance. 
The aim of this project is to equip and empower patients known to be at high risk of acute 
coronary syndromes to seek urgent medical help without going to the hospital, if they 
experience symptoms, and to make a decision to present to the emergency services whenever 
necessary. This serves two aims: 1) ensuring that patients present appropriately to the 
emergency services if needed, and 2) to prevent unnecessary presentations, as assessed by 
well-validated technologies coupled with an urgent remote consultation with a specialist.  
 
 
 
3. STUDY DESIGN 
 
The study will be conducted at the Hammersmith Hospital. Patients will be recruited from the 
cardiology clinical areas of Hammersmith Hospital (i.e. the Heart Assessment Centre, Cardiac 
Day Ward or A7 Ward). We propose to utilise a bespoke hybrid remote telemonitoring system 
to assess patients who are discharged from hospital following an acute myocardial infarction 
and the format of a randomised controlled trial will be used to achieve the aims of this project. 
 
The participants will choose between these two telemedicine packages, desponds on patient 
preference and devices availability:  
 
The 1st telemedicine package will consist of the following equipment: 
• 
SHL smartheart (SHL Telemedicine, Tel Aviv, Israel), FDA-approved and CE-marked 
• 
Omron Basic M2 blood pressure monitor (Omron Corporation, Kyoto, Japan), CE-
marked and validated by the British & Irish Hypertension Society  
• 
Kinetik Wellbeing Finger Pulse Oximeter (Kinetik Wellbeing, Surrey, UK), CE-marked 
 
The 2nd telemedicine package will consist of the following equipment: 
• 
SHL smartheart (SHL Telemedicine, Tel Aviv, Israel), FDA-approved and CE-marked. 
• 
Current Health (Respiration rate, Oxygen saturation, Pulse rate, Body temperature and 
Mobility & step count), FDA-approved and CE-marked. 
• 
iHealth Feel Wireless Blood Pressure Monitor, FDA-approved and CE-marked. 
 
 
 

 
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à 
SHL smartheart + BP/Sats: Patient develops possible cardiac symptoms, takes an 
ECG, BP and oxygen saturation as per their training. Activated text which goes to trial 
phone (Active: Mon – Fri between 07:00 to 23:00). Trial Coordinator (TC) receives text 
and then contacts patient to obtain details, BP, O2sat and views uploaded ECG. TC 
provides the trial cardiologist with patient past medical history from trial documentation, 
forwards ECG, calls the trial cardiologist with patient details, BP, O2sat, and current 
chief complaint. Patient will receive a phone call by the trial cardiologist who will have 
access to a high-quality ECG trace, as well as blood pressure and oxygen saturations, 
and coupled with the clinical history, can decide on the most appropriate course of 
further management.  
à 
SHL Smartheart + Current Health: Patient develops possible cardiac symptoms, 
takes an ECG, BP and oxygen saturation as per their training. Activated text which 
goes to trial phone (Active: Mon – Fri between 07:00 to 23:00). TC receives text and 
then contacts patient to obtain details, BP, O2sat and views uploaded ECG. TC 
provides the trial cardiologist with patient past medical history from trial documentation, 
forwards ECG, calls the trial cardiologist with patient details, BP, O2sat, and current 
chief complaint. Patient will receive a phone call by the cardiologist who will conduct 
an emergency video consultation using Current Health platform, an approved web-
based platform. The trial cardiologist will have access to a high-quality ECG trace, as 
well as blood pressure, respiration rate, oxygen saturation, pulse rate, body 
temperature, and coupled with the clinical history, can decide on the most appropriate 
course of further management. 
 
The disadvantages of taking part include needing to train to use the equipment, which is 
usually straight forward. There is a very small risk that an incorrect decision is made by the 
research team, the participant is not treated when he/she could have been. However, this is a 
very small risk, as the research team are experienced, and the clinical decision support 
algorithm has been designed to be safe. 
 
The participant will have adequate training prior to discharge for these two telemedicine 
packages by the local research fellow and cardiac research nurse, covering how and when to 
perform the home monitoring and how to contact the clinical trial team. There will be follow up 
training calls to perform a remote ECG, within 2 weeks; 4 weeks and 8 weeks from discharge.  
 
The patient will be informed that monitoring is available Monday - Friday between 07:00 and 
23:00. If the patient develops chest pain wakening from sleep or other significant 
cardiovascular symptoms during the night, the patient will be advised to contact 111 or 999. If 
a participant does not hear from the trial cardiology team within 15 minutes of trigging an ECG, 
participant should do what he/she normally would do by contacting 111 or 999. 
 
A total of 338 patients will be randomised 1:1 using computer randomisation software to the 2 
trial arms over 9 months. Patients in the intervention group will be discharged from hospital 
with the telemedicine package as outlined above. In the active arm when patients seek 
medical attention by performing an ECG, the data provided by the telemedicine package will 
be acted upon, as appropriate, by the trial team. Conversely, in the control arm, standard 
routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 
months.   

 
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In the active arm, the patient's smartphone will be paired with the SHL ‘Smartheart’ and they 
should perform an ECG with the ‘Smartheart’ before discharge. Depending on which 
telemedicine package the participant chooses; they will receive a phone call or one of the trial 
cardiologists will conduct an emergency video consultation using the Current Health platform. 
When the patient experiences chest discomfort, acute breathlessness, sustained palpitations 
or other cardiovascular symptoms and requires attention, they will take an ECG, BP and 
oxygen saturation as per their training. A text SMS message is activated which goes to the 
trial phone (Active: Mon – Fri between 07:00 to 23:00). The TC receives the SMS text and 
then contacts the patient to obtain details. The cardiologist will have access to a high-quality 
ECG trace, as well as blood pressure, pulse rate and oxygen saturations (if using the 
SmartHeart + BP/Sats), as well as respiratory rate and body temperature reading (if using the 
SmartHeart + Current Health package). This clinical information, coupled with the history from 
the patient and guided by the clinical decision support algorithm (Appendix 3), will inform the 
trial cardiology team on the most appropriate course of further management (1 of 4 possible 
scenarios, as outlined in the flow diagram above). On each occasion that the telemedicine 
package is used, the outcomes will be documented by the trial cardiologist on the electronic 
record system and detailed on a study record form, with appropriate follow up arranged for 
that specific event. 
 
Patients will retain the telemonitoring package for the first 6 months following discharge, with 
remote follow up over the phone at 3 months, and again at 6 months and 9 months. The 
telephone review will assess any admissions/ presentations to emergency services and the 
use of the telemedicine package. Patients will undertake a self-filled quality of life 
questionnaires [ The Short Form (36) Health Survey and The Seattle Angina Questionnaire-7 
(SAQ-7)] at baseline pre-discharge, as well as at 3, 6 and 9 months post-discharge. 
 
A total of 338 patients will be randomised 1:1 to the two management arms over 9 months. 
 
 
3.1. 
STUDY OUTCOME MEASURES 
The primary outcome is: 
• All hospital readmission rates (formal admissions and not emergency room 
visits) at 6 months of follow up in intervention vs control groups. 
The secondary outcomes are: 
1) Total length of stay (LOS) at 3, 6, and 9 months.  
2) Myocardial infarction, stroke and all-cause mortality at 9-months. We will also 
report data on heart failure and cardiovascular mortality and morbidity. 
3) Medical intervention for acute coronary syndromes or heart failure, including 
coronary angiography/ angioplasty, injectable therapy or oxygen therapy. 
4) Emergency Room visits not requiring admission or further intervention. 
5) 9 months readmission rates (with 3 months without intervention) to investigate 
learning effect of intervention.  
6) Patient-reported quality of life outcome measures (weighted to treatment 
satisfaction domains).  
 
 

 
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4. PARTICIPANT ENTRY 
 
4.1. 
PRE-REGISTRATION EVALUATIONS  
 
No specific pre-registration evaluations are required. All study assessments 
are made post-randomization. The study will be conducted at the 
Hammersmith Hospital. Patients will be recruited from the cardiology clinical 
areas of Hammersmith Hospital (i.e. the Heart Assessment Centre, Cardiac 
Day Ward or A7 Ward). We will recruit patients who are discharged from 
hospital following an acute myocardial infarction.  
 
 
4.2. 
INCLUSION CRITERIA  
 
1. ACS Patients diagnosed with elevated high-sensitivity troponin I who 
have undergone coronary intervention for non-ST-segment acute 
coronary syndrome (NSTE-ACS) or ST-segment elevation myocardial 
infarction (STEMI) or unstable angina (UA).  
2. In addition, the patients must have at least one additional cardiovascular 
risk factors: 
• Current or ex-smoker 
• Diagnosed with hypertension 
• Diabetes mellitus 
• Hypercholesterolaemia. 
• Male aged > 50 years.  
3. The patient must have access to a smartphone or smart device.   
 
4.3. 
EXCLUSION CRITERIA 
1- The inability to apply the telemedicine equipment/ transmit the ECG 
via Bluetooth or cellular connectivity/ engage in a virtual consultation. 
2- Life expectancy of 9 months or less.   
 
4.4. 
WITHDRAWAL CRITERIA  
 
The participant would need to be fully aware, in order to participate further in 
the trial, so If a participant loses capacity to consent during the study, they will 
be withdrawn.  
 
5. ADVERSE EVENTS  
 
5.1. 
DEFINITIONS  
Adverse Event (AE): any untoward medical occurrence in a patient or clinical study subject.   
 
Serious Adverse Event (SAE): any untoward and unexpected medical occurrence or effect 
that: 
• 
Results in death 

 
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• 
Is life-threatening – refers to an event in which the subject was at risk of death 
at the time of the event; it does not refer to an event which hypothetically might 
have caused death if it were more severe 
 
• 
Requires 
hospitalisation, 
or 
prolongation 
of 
existing 
inpatients’ 
hospitalisation 
• 
Results in persistent or significant disability or incapacity 
• 
Is a congenital anomaly or birth defect 
 
Medical judgement should be exercised in deciding whether an AE is serious in other 
situations.  Important AEs that are not immediately life-threatening or do not result in death or 
hospitalisation but may jeopardise the subject or may require intervention to prevent one of 
the other outcomes listed in the definition above, should also be considered serious. 
 
5.2. 
REPORTING PROCEDURES  
All adverse events should be reported.  Depending on the nature of the event the reporting 
procedures below should be followed.  Any questions concerning adverse event reporting 
should be directed to the Chief Investigator in the first instance.   
 
5.3.1 Non serious AEs 
All such events, whether expected or not, should be recorded- it should be specified if only 
some non-serious AEs will be recorded, any reporting should be consistent with the purpose 
of the trial end points.  
 
5.3.2 Serious AEs 
An SAE form should be completed and emailed to the Chief Investigator within 24 hours.  
However, relapse and death due to myocardial infarction, and hospitalisations for elective 
treatment of a pre-existing condition do not need reporting as SAEs. 
 
All SAEs should be reported to the London - Fulham Research Ethics Committee where in the 
opinion of the Chief Investigator, the event was: 
• 
‘related’, ie resulted from the administration of any of the research procedures; 
and 
• 
‘unexpected’, ie an event that is not listed in the protocol as an expected 
occurrence 
 
Reports of related and unexpected SAEs should be submitted within 15 days of the Chief 
Investigator becoming aware of the event, using the NRES SAE form for non-IMP studies.  
The Chief Investigator must also notify the Sponsor of all related and unexpected SAEs. 
 
Local investigators should report any SAEs as required by their Local Research Ethics 
Committee, Sponsor and/or Research & Development Office. 
 
Contact details for reporting SAEs 
RGIT@imperial.ac.uk 
CI email (and contact details below) 
Fax: +44(0)2076811775, attention  
Please send SAE forms to: r.khamis@imperial.ac.uk  
Tel: +44(0)2075946842 (Mon to Fri 09.00 – 17.00) 

 
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6. ASSESSMENT AND FOLLOW-UP  
 
A total of 338 patients will be randomised 1:1 to the two management arms over 9 months. 
Patients will be randomised in a 1:1 fashion using computer randomisation software to the 2 
trial arms. Patients in the intervention group will be discharged from hospital with the 
telemedicine package as outlined above. However, in the active arm when patients seek 
medical attention, the data provided by the telemedicine package will be acted upon, as 
appropriate, by the trial cardiologist. Conversely, in the control arm, stranded routine clinical 
care carried out, with remote follow up over the phone at 3 months, and again at 6 and 9 
months.    
  
The research team and the direct care team will review all the results/findings including the 
incidental findings and these findings will be documented. Additionally, these findings will be 
reported to the chief investigator of this study, the participant’s GP, clinical care team. 
  
To measure our primary and secondary outcomes, we will use the informatics infrastructure 
at Imperial College Healthcare NHS Foundation Trust to extract follow-up data on hospital 
readmissions from primary and secondary care electronic health care records at the defined 
time periods of 6 and 9 months, as per protocol.  
 
In particular, for those admitted to Imperial College Healthcare NHS Trust, we will use the 
NIHR Health Informatics Collaborative to extract data on patient demographics, hospital 
admission details including length of stay and discharge diagnosis, blood test results, imaging, 
and procedure requests (and results, where available). For those admitted to a different 
hospital within North West London, we will be using the Whole System Integrated Care (WSIC) 
dataset. Whilst the WSIC dataset does not hold granular procedural or blood test data, patient 
demographic and hospital admission data will be accessible for extraction 
 
We plan to run this pilot study for 22-month, from December 2021 to September 2023, 
recruiting 338 patients and following them each up for 9 months. The intervention will be 
stopped at 6 months but both groups will be followed up until 9 months. We intend to be able 
to analyse the full results at 22-month from first recruitment, after follow-up has completed and 
initial data analysis taken place. 
 
The end of study happens by the end of recruiting 338 patients and following them each up 
for 9 months.  
 
7. STATISTICS AND DATA ANALYSIS 
 
We estimated that the baseline event rate for readmission in the standard therapy arm would 
be 30% readmission at 6 months, with a relative hazard of 0.5 for the telemedicine arm. 
Assuming a high censoring rate of 15% in each arm due to competing risks and withdrawal of 
consent due to difficulty with the telemedicine protocol, we calculated a total of 338 patients 
with a 1:1 randomisation ratio would provide 80% power at a two tailed alpha of 0.05. 
 
 
 
 

 
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8. REGULATORY ISSUES  
 
8.1. 
ETHICS APPROVAL  
 
The Study Coordination Centre has obtained approval from the London - Fulham 
Research Ethics Committee (REC) and Health Research Authority (HRA). The study 
must also receive confirmation of capacity and capability from each participating NHS 
Trust before accepting participants into the study or any research activity is carried 
out. The study will be conducted in accordance with the recommendations for 
physicians involved in research on human subjects adopted by the 18th World 
Medical Assembly, Helsinki 1964 and later revisions.  
 
8.2. 
CONSENT   
 
Informed consent will be sought after discussion between the recruitment team and 
patient. Patient information sheets will be freely available. To be randomised and 
proceed into the study patients will have to provide written consent and the trial 
consent form. All participants are free to withdraw at any time from the protocol 
treatment without giving reasons and without prejudicing further treatment. 
 
8.3. 
CONFIDENTIALITY  
 
The Chief Investigator will preserve the confidentiality of participants taking part in 
the study and is registered under the Data Protection Act. 
 
8.4. 
INDEMNITY 
 
Imperial College London holds negligent harm and non-negligent harm insurance 
policies which apply to this study.  
 
8.5. 
SPONSOR  
 
Imperial College London will act as the main Sponsor for this study.  Delegated 
responsibilities will be assigned to the NHS trusts taking part in this study.   
 
8.6. 
FUNDING  
King Khalid University (KKU) is funding this study. KKU funds the consumables for 
this project.  
 
8.7. 
AUDITS   
 
The study may be subject to audit by Imperial College London under their remit as 
sponsor and other regulatory bodies to ensure adherence to GCP and the UK Policy 
Frame Work for Health and Social Care Research.  
 
 
 
9. STUDY MANAGEMENT  
 

 
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The day-to-day management of the study will be co-ordinated through the trial team. There 
will be Steering, Safety and Endpoint committees appointed to oversee the study. 
Furthermore, a data monitoring committee will adjudicate the trial safety on a weekly basis.  
 
 
10. PUBLICATION POLICY  
 
Trial results will be released in several manuscripts providing outcomes of the trial as a whole. 
All publications and presentations relating to the trial will be authorised by the Trial Steering 
Committee. Named authors will include the Investigators from all participating investigational 
centres. We will aim to publish our findings and use this study to decide on a large multicentre 
randomised controlled trial.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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11. REFERENCES 
 
1. 
Kwok CS, Wong CW, Shufflebotham H, Brindley L, Fatima T, Shufflebotham A, et al. 
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Acute Myocardial Infarction: A Prospective Observational Study. Circulation. 2017. 
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Khera R, Wang Y, Bernheim SM, Lin Z, Krumholz HM. Post-discharge acute care and 
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Research Governance 
           and Integrity Team 
 
 
 
 
TELE-ACS Protocol V1.1 
1st December 2021 
 
Page 18 of 21 
IRAS Project ID: 291565 
 
  
 
12. EXAMPLES APPENDICES 
 
Appendix 1. Summary of investigations, treatment and assessments 
 
Exam 
Week of Treatment 
 
Patient admitted with 
ACS nearing hospital 
discharge 
1 
2 
3 
4 
8 
12 
24 
36 
Informed consent  
X 
 
 
 
 
 
 
 
 
PIS provided to patient 
X 
 
 
 
 
 
 
 
 
Patient recruited 
X 
 
 
 
 
 
 
 
 
Confirmation that ACS Patients 
diagnosed with elevated high-
sensitivity troponin I who have 
undergone coronary intervention for 
non-ST-segment acute coronary 
syndrome (NSTE-ACS) or ST-segment 
elevation myocardial infarction 
(STEMI) or unstable angina (UA).  
 
X 
 
 
 
 
 
 
 
 
Confirmation that the patient would 
have adequate training prior to 
discharge for these two telemedicine 
packages by the local research fellow 
and cardiac research nurse, covering 
how and when to perform the home 
monitoring and contact the on-call 
cardiology team. 
 
 
X 
 
 
 
 
 
 
 
 
Follow up training calls with these 
patients, to perform a remote ECG, 
within a few weeks from discharge. 
 
 
 
X 
 
 
X 
 
X 
 
 
 
Self-filled quality of life questionnaire 
X 
 
 
 
 
 
X 
X 
X 
3 months follow up (over the phone) 
 
 
 
 
 
 
X 
 
 
6 months follow up (over the phone) 
 
 
 
 
 
 
 
X 
 
9 months follow up (over the phone) 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 

 
Research Governance 
           and Integrity Team 
 
 
 
 
TELE-ACS Protocol V1.1 
1st December 2021 
 
Page 19 of 21 
IRAS Project ID: 291565 
 
  
Appendix 2 – TELE-ACS trial workflow 
 
Workflow  
Person 
responsible  
Comments  
The electronic healthcare records will be 
automatically screened to identify cases that 
satisfy the following ‘structured’ data:  
 
Inclusion criteria:  
• 
ACS Patients (NSTEMI or STEMI or 
UA) and diagnosed with Elevation of 
hsTnI > upper limit of normal 
• 
Undergoing PCI during admission 
• 
1 of following risk factors:  
• 
Hypertension  
• 
Diabetes Mellitus  
• 
Current or ex- smoker  
• 
Hypercholesterolaemia  
• 
Male aged > 50 years.  
• 
The patient must have access to 
smartphone 
Exclusion criteria:   
• 
The inability to apply the telemedicine 
equipment/ transmit the ECG via 
Bluetooth or cellular connectivity/ 
engage in a virtual consultation.   
• 
Life expectancy of 9 months or less.    
HIC Team*  
The HIC team will generate an 
eligibility criteria dataset based on 
screening the ‘structured’ data 
components of all inclusion criteria 
and specific exclusion criteria.  
 
Comorbidity data will be extracted 
using ICD-10 and SNOMED codes 
from historical patient encounters. 
 
A HIC patient list will be generated 
following this automated screen. 
 
A new patient list will be provided to 
the research team on a daily basis.  
  
The research fellow/nurse will review the HIC 
patient list against all exclusion criteria.  
Research Nurse  
 
Eligibility verified by Doctor  
Research 
Fellow  
 
Consent form given to patient 
Research fellow 
/Nurse  
 
PIS given to patient  
Ward/ Research 
Team  
 
Eligible patients randomised  
Research 
Fellow/Nurse  
Electronic randomisation with age 
and sex matching  
ACTIVE arm - Call ward team to determine if 
consent signed, not given or more information 
requested.  
Research 
Fellow/ Nurse  
Research Nurse will: 
• 
provide & discuss additional 
information  
• 
Collect consent forms  
• 
Ensure patients have 
adequate training prior to 
discharge for the 
telemedicine packages 
CONTROL Arm - Call ward team to determine 
if consent signed, not given or more 
information requested  
 
Research 
Fellow/Nurse will 
provide & 
discuss  
Research Fellow/Nurse will: 
• 
Provide & discuss additional 
information 
• 
Collect consent forms 
• 
inform ward team that no 
other intervention is required 
 
 
 
Daily review of results  
Research 
Fellow  
Database will automatically alert for 
any safety issues that we specify e.g. 
Dangerous ECG rhythms.  

 
Research Governance 
           and Integrity Team 
 
 
 
 
TELE-ACS Protocol V1.1 
1st December 2021 
 
Page 20 of 21 
IRAS Project ID: 291565 
 
  
Research Team will: 
• 
review the data and any 
alerts  
• 
check clinical team are aware 
for review any potential risk to 
participants. 
Safety monitoring  
Research fellow  The chief investigator and the 
research team will review any adverse 
events in case study need to be 
stopped early.  
When patient discharged, there will be a 
follow up training calls with these patients, to 
perform a remote ECG, within a few weeks 
from discharge 
Research Fellow Ensure patient discharged will have a 
follow up training calls with these 
patients, to perform a remote ECG, 
within 2 weeks; 4 weeks and 8 weeks 
from discharge 
Self-filled quality of life questionnaire 
Research 
Fellow  
Patients will undertake a self-filled 
quality of life questionnaire at baseline 
pre-discharge, as well as at 3, 6 and 9 
months post-discharge. 
3-month follow-up  
Research Fellow Patient will receive remote follow up 
over the phone by the Research 
Fellow at 3 months  
6-month follow-up 
Research Fellow Patient will receive remote follow up 
over the phone by the Research 
Fellow at 6 months  
9-month follow-up 
Research Fellow Patient will receive remote follow up 
over the phone by the Research 
Fellow at 9  months  
 
*HIC Team:  
The NIHR Health Informatics Collaborative (HIC) was initially made up of five BRCs and their respective NHS Trusts 
and university partners – Oxford University Hospitals NHS Foundation Trust, Imperial College Healthcare NHS Trust, 
Guy's and St Thomas' NHS Foundation Trust/Kings College Hospital NHS Foundation Trust, Cambridge University 
Hospitals NHS Foundation Trust and University College London Hospitals NHS Foundation Trust. Since then the 
collaborative has expanded to include 23 NHS Trusts from across England.  
 
The aim of the HIC is to improve the availability and quality of routinely captured hospital data and to make it available 
for multi-site translational research. The collaborative then uses this data in an anonymised form to answer pressing 
clinical and research questions, helping us understand the complex care delivered in the NHS and how care can be 
improved to provide the best services to patients.  
Collecting data directly from electronic patient record systems drastically reduces the time and cost for data collection 
for research and allows for the creation of much larger datasets compared to traditional research projects, which rely on 
recruiting patients individually.  
 
The use of routinely captured data does however also bring its own challenges. The fact that each participating NHS 
site has its own electronic patient record system means that data are captured differently at each trust; this can make 
the process of compiling all sites’ data into one dataset challenging. Additionally, not all data are collected electronically 
at each site, and large amounts of crucial electronic data are often recorded in free text rather than in a structured 
format.  
 
The HIC overcomes these issues by creating data warehouses at each site that read in and transform data to 
standardised structures and formats, validating and cataloguing data so that it is clear what the data was captured for 
and how it should be used. The collaborative also has projects running that aim to extract structured data from free text 
and share methods and codes across the NHS to reduce duplication of methods.  
 
 
 
Appendix 3. Clinical decision support algorithm 
 

 
Research Governance 
           and Integrity Team 
 
 
 
 
TELE-ACS Protocol V1.1 
1st December 2021 
 
Page 21 of 21 
IRAS Project ID: 291565 
 
  
Assessment Categories 
Scoring Criteria 
 
 
 
 
 
Symptoms 
 
Palpitations 
Absent  
Present 
 
Chest Pain 
No Symptoms 
 New or worsening chest Pain 
Shortness of breath 
(SOB) 
Absent 
New or worsening SOB 
 
Dizziness 
Absent 
Presyncope 
Syncope 
 
 
Heart Rate 
Heart rate 50 to 110 bpm 
Heart rate 110 -150 bpm 
Heart rate 35 -50 bpm 
Heart rate ≥150 bpm 
Heart rate <35 bpm 
 
Blood Pressure 
SBP 90 – 170 mmHg 
SBP ≥170 mmHg             
SBP <90 mmHg              
 
Saturation (SpO2) 
 
100% - 94% 
93% - 90% 
< 89%  
 
 
 
 
 
 
ECG 
Normal sinus rhythm (HR: 50 - 100 bpm) 
New Sinus tachycardia (HR ~120 bpm) 
 New Sinus bradycardia (HR <50 bpm)  
New Atrial arrhythmia: Atrial flutter & Atrial fibrillation 
New horizontal or downsloping ST-depression ≥ 0.5 mm in two contiguous 
leads and/or T inversion > 1 mm in two contiguous leads with prominent R 
wave or R/S ratio > 1  
Severe bradycardia (HR <35 bpm) or complete heart block 
New Left bundle branch block (LBBB) 
Ventricular tachycardia 
New ST-elevation at the J-point in two contiguous leads with the cut-point: ≥ 1 
mm in all leads other than leads V2–V3 where the following cut-points apply: 
≥ 2mm in men ≥ 40 years; ≥ 2.5 mm in men < 40 years, or ≥ 1.5 mm in women 
regardless of age 
 
The action taken post assessment- Intervention:   
1. All green - Reassure and routine follow up with cardiology or GP as previously planned 
2. One amber - GP visit  
3. Two ambers or more- A and E or if not possible 999.  
4. One red – 999