Telemedicine in High-Risk Cardiovascular Patients Post-ACS (TELE-ACS)

February 25, 2026 updated by: Imperial College London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

337

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W12 0NN
        • Imperial College Healthcare NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Arm
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
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.
Placebo Comparator: Control Arm
Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
Other: Control Arm
Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Hospital Readmission at 6 Months
Time Frame: 6 months
At 6 months of follow up, compare formal admissions and not emergency room visits in intervention to control groups.
6 months
Emergency Department Visits at 6 Months
Time Frame: 6 Months
Any emergency department visits not requiring admission or further intervention will be compared in both study groups at 6 months of follow up.
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay
Time Frame: From discharge to 9 months follow-up
Length of stay at 3, 6, and 9 months will be compared in both study groups.
From discharge to 9 months follow-up
All-cause Mortality
Time Frame: 6 months
At 6 months of follow up, compare all-cause mortality, morbidity
6 months
Number of Participants With Major Adverse Cardiac Events (MACE) at 9 Months
Time Frame: 9 months
Number of participants with major adverse cardiac events (MACE) at 9 months follow-up.
9 months
Medical Intervention
Time Frame: 6 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.
6 months
9 Months Readmission Rates
Time Frame: 9 months
The readmission rates for 9 months will be compared in both study groups.
9 months
Patient-Reported Quality of Life - 3 Months
Time Frame: 3 months
Quality of life was assessed using the SF-36 and Seattle Angina Questionnaire-7 (SAQ-7). Both instruments generate domain scores from 0-100, with higher scores indicating better health status or angina-related quality of life. Questionnaires were completed at baseline (pre-discharge) and 3 months post-discharge, and follow-up scores were compared with baseline values.
3 months
Patient-Reported Quality of Life - 6 Months
Time Frame: 6 months
Quality of life was assessed using the SF-36 and Seattle Angina Questionnaire-7 (SAQ-7). Both instruments generate domain scores from 0-100, with higher scores indicating better health status or angina-related quality of life. Questionnaires were completed at baseline (pre-discharge) and 6 months post-discharge, and follow-up scores were compared with baseline values.
6 months
Patient-Reported Quality of Life - 9 Months
Time Frame: 9 months
Quality of life was assessed using the SF-36 and Seattle Angina Questionnaire-7 (SAQ-7). Both instruments generate domain scores from 0-100, with higher scores indicating better health status or angina-related quality of life. Questionnaires were completed at baseline (pre-discharge) and 9 months post-discharge, and follow-up scores were compared with baseline values.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

King Khalid University

Investigators

  • Principal Investigator: Ramzi Y Khamis, MB ChB PhD FRCP, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2022

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

May 31, 2025

Study Registration Dates

First Submitted

August 11, 2021

First Submitted That Met QC Criteria

August 16, 2021

First Posted (Actual)

August 20, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21HH7034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Once the study is complete and analysed, whilst individual patient results will not be disclosed, the overall research findings may be submitted for publication in a scientific journal and presented at scientific conferences following the completion of the study. A summary of the research findings will be uploaded onto the Imperial College London website. All data will be anonymised and kept confidential.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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