Telemedicine in High-Risk Cardiovascular Patients Post-ACS

Study Overview
=================
Brief Summary
-----------------
This is a non-CTIMP randomised controlled trial looking at the utilisation of telemedicine devices to provide remote, clinically necessary, diagnostic information, without the need for hospital attendance that patients will take home with them following admission to hospital with a heart attack.

Detailed Description
-----------------
Following hospital admission with a heart attack, telemedicine equipment can provide patients with remote, clinically necessary diagnostic information without the need for hospital attendance, which they can take home when they discharge from the hospital. In this project, patients known to be at high risk of ACS are equipped and empowered to seek urgent medical attention without visiting the hospital, if they experience symptoms, and to determine whether or not to seek emergency treatment, with an immediate remote specialist consultation, as assessed by validated technology. Those enrolled in the intervention group will be offered telemedicine packages upon discharge from the hospital. Those enrolled in the active arm will have their telemedicine package provided to the trial team when they conduct an ECG and seek medical attention. In contrast, in the control group, routine clinical care will be provided, as well as follow up by phone over 9 months.

Official Title
-----------------
Remote Acute Assessment of Patients With High Cardiovascular Risk Post-Acute Coronary Syndrome

Conditions
-----------------
Cardiovascular Diseases, Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Other: Active Arm
* Other: Control Arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1 ACS Patients diagnosed with elevated hs-cTnI I who have undergone coronary intervention for NSTEMI or STEMI or unstable angina. 2 In addition, the participant should have at least one additional cardiovascular risk factor: Current or ex-Tobacco Use Hypertension Diabetes Hypercholesterolaemia. Male aged > 50 years. 3 Access to a smartphone or smart device. Exclusion Criteria: 1 The inability to apply/use the telemonitoring equipmentt 2 Life expectancy of 9 months or less.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A total of 338 patients will be randomised 1:1 to the 2 trial arms over 9 months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Arm<br>Patients will be discharged from the hospital with the telemedicine package. If the patient develops possible cardiac symptoms and seeks medical attention, the data provided by the telemedicine package will be acted upon, as appropriate, by the trial cardiology team. With remote follow up over the phone at 3, 6 and 9 months. | Other: Active Arm<br>* Patient develops possible cardiac symptoms, takes an ECG, BP and oxygen saturation as per their training. 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. With remote follow up over the phone at 3, 6 and 9 months.<br>|
| Placebo Comparator: Control Arm<br>Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months. | Other: Control Arm<br>* Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All hospital readmission rates | At 6 months of follow up, compare formal admissions and not emergency room visits in intervention to control groups. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Length of stay at 3, 6, and 9 months will be compared in both study groups. | 9 months | 
| All-cause mortality, morbidity, and MACE. | At 9 months of follow up, compare all-cause mortality, morbidity, and MACE. | 9 months | 
| Medical intervention | Compare Medical intervention for for acute coronary syndromes or heart failure, including coronary angiography/ angioplasty, injectable therapy or oxygen therapy for both study groups when readmission to hospital. | 9 months | 
| Emergency Department visits | Any emergency department visits not requiring admission or further intervention will be compared in both study groups at 9 months of follow up. | 9 months | 
| 9 months readmission rates | The readmission rates for 9 months will be compared in both study groups. | 9 months | 
| Patient-reported quality of life | Patients in both study groups will fill out a quality of life questionnaires | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial infarction, Acute coronary syndrome, Telemedicine, Heart Attack