Clinical trial NCT05015634: Telemedicine in High-Risk Cardiovascular Patients Post-ACS
Official title: Remote Acute Assessment of Patients With High Cardiovascular Risk Post-Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Acute Coronary Syndrome
Keywords: Myocardial infarction
Acute coronary syndrome
Telemedicine
Heart Attack
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: King Khalid University
First posted: 2021-08-20
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 338 patients will be randomised 1:1 to the 2 trial arms over 9 months.
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: All hospital readmission rates
timeFrame: 6 months
Secondary outcomes:
measure: Length of stay
timeFrame: 9 months
measure: All-cause mortality, morbidity, and MACE.
timeFrame: 9 months
measure: Medical intervention
timeFrame: 9 months
measure: Emergency Department visits
timeFrame: 9 months
measure: 9 months readmission rates
timeFrame: 9 months
measure: Patient-reported quality of life
timeFrame: 9 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Ramzi Y Khamis, MB ChB PhD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ben-Assa E, Shacham Y, Golovner M, Malov N, Leshem-Rubinow E, Zatelman A, Oren Shamir A, Rogowski O, Roth A. Is telemedicine an answer to reducing 30-day readmission rates post-acute myocardial infarction? Telemed J E Health. 2014 Sep;20(9):816-21. doi: 10.1089/tmj.2013.0346. Epub 2014 Jul 21.
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