Telemedicine in High-Risk Cardiovascular Patients Post-ACS

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Acute Coronary Syndrome

• Registration Number: NCT05015634
• Lead Sponsor: Imperial College London

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.

Study Timeline

• Study First Submitted: 2021-08-11
• Study First Submitted QC: 2021-08-16
• Study First Posted: 2021-08-20
• Study Start: 2022-01-06
• Primary Completion: 2025-02-28
• Study Completion: 2025-05-31
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 337

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
All hospital readmission rates	6 months	At 6 months of follow up, compare formal admissions and not emergency room visits in intervention to control groups.

Secondary Outcome Measures

Name	Time	Method
Length of stay	9 months	Length of stay at 3, 6, and 9 months will be compared in both study groups.
All-cause mortality, morbidity, and MACE.	9 months	At 9 months of follow up, compare all-cause mortality, morbidity, and MACE.
Medical intervention	9 months	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.
Emergency Department visits	9 months	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 readmission rates	9 months	The readmission rates for 9 months will be compared in both study groups.
Patient-reported quality of life	9 months	Patients in both study groups will fill out a quality of life questionnaires

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom