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Cardiovascular DiseasesTELE-ACSNCT05015634

Telemedicine in High-Risk Cardiovascular Patients Post-ACS

A study testing Active Arm in people with Cardiovascular Diseases and Acute Coronary Syndrome, run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Active Arm
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
337 participants
Where
1 siteUnited Kingdom
Study dates
6 Jan 2022to 31 May 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 1 The inability to apply/use the telemonitoring equipmentt
  • 2 Life expectancy of 9 months or less.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Imperial College Healthcare NHS Trust

    London, W12 0NN

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
Active Arm, Control Arm
Keywords
Myocardial infarction, Acute coronary syndrome, Telemedicine, Heart Attack
Medical subject headings
Cardiovascular Diseases, Acute Coronary Syndrome, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active ArmOther

    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.

  • Control ArmOther

    Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.

Study groups in NCT05015634
Study groupRoleWhat they receive
Active ArmActive comparatorPatients 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.
Receives: Other: Active Arm
Control ArmPlacebo comparatorStandard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
Receives: Other: Control Arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Hospital Readmission at 6 Months

    At 6 months of follow up, compare formal admissions and not emergency room visits in intervention to control groups.

    Measured: 6 months

  2. Emergency Department Visits at 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.

    Measured: 6 Months

Secondary outcomes (8)
  1. Length of Stay

    Length of stay at 3, 6, and 9 months will be compared in both study groups.

    Measured: From discharge to 9 months follow-up

  2. All-cause Mortality

    At 6 months of follow up, compare all-cause mortality, morbidity

    Measured: 6 months

  3. Number of Participants With Major Adverse Cardiac Events (MACE) at 9 Months

    Number of participants with major adverse cardiac events (MACE) at 9 months follow-up.

    Measured: 9 months

  4. 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.

    Measured: 6 months

  5. 9 Months Readmission Rates

    The readmission rates for 9 months will be compared in both study groups.

    Measured: 9 months

  6. Patient-Reported Quality of Life - 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.

    Measured: 3 months

  7. Patient-Reported Quality of Life - 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.

    Measured: 6 months

  8. Patient-Reported Quality of Life - 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.

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2021
  2. Study start6 Jan 2022
  3. Primary completion28 Feb 2025
  4. Study completion31 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
A total of 338 patients will be randomised 1:1 to the 2 trial arms over 9 months.
Masking
None (open label)
Enrolment
337 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05015634
Sponsor's protocol ID
21HH7034
Acronym
TELE-ACS
Status last verified
Feb 2026
First submitted
11 Aug 2021
Last updated
17 Mar 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Kwok CS, Wong CW, Shufflebotham H, Brindley L, Fatima T, Shufflebotham A, Barker D, Pawala A, Heatlie G, Mamas MA. Early Readmissions After Acute Myocardial Infarction. Am J Cardiol. 2017 Sep 1;120(5):723-728. doi: 10.1016/j.amjcard.2017.05.049. Epub 2017 Jun 15.

    PubMed 28728745
  • Wang H, Zhao T, Wei X, Lu H, Lin X. The prevalence of 30-day readmission after acute myocardial infarction: A systematic review and meta-analysis. Clin Cardiol. 2019 Oct;42(10):889-898. doi: 10.1002/clc.23238. Epub 2019 Aug 12.

    PubMed 31407368
  • Southern DA, Ngo J, Martin BJ, Galbraith PD, Knudtson ML, Ghali WA, James MT, Wilton SB. Characterizing types of readmission after acute coronary syndrome hospitalization: implications for quality reporting. J Am Heart Assoc. 2014 Sep 18;3(5):e001046. doi: 10.1161/JAHA.114.001046.

    PubMed 25237046
  • Dreyer RP, Dharmarajan K, Kennedy KF, Jones PG, Vaccarino V, Murugiah K, Nuti SV, Smolderen KG, Buchanan DM, Spertus JA, Krumholz HM. Sex Differences in 1-Year All-Cause Rehospitalization in Patients After Acute Myocardial Infarction: A Prospective Observational Study. Circulation. 2017 Feb 7;135(6):521-531. doi: 10.1161/CIRCULATIONAHA.116.024993.

    PubMed 28153989
  • Khera R, Wang Y, Bernheim SM, Lin Z, Krumholz HM. Post-discharge acute care and outcomes following readmission reduction initiatives: national retrospective cohort study of Medicare beneficiaries in the United States. BMJ. 2020 Jan 15;368:l6831. doi: 10.1136/bmj.l6831.

    PubMed 31941686
  • 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.

    PubMed 25046174
  • Garcia S, Albaghdadi MS, Meraj PM, Schmidt C, Garberich R, Jaffer FA, Dixon S, Rade JJ, Tannenbaum M, Chambers J, Huang PP, Henry TD. Reduction in ST-Segment Elevation Cardiac Catheterization Laboratory Activations in the United States During COVID-19 Pandemic. J Am Coll Cardiol. 2020 Jun 9;75(22):2871-2872. doi: 10.1016/j.jacc.2020.04.011. Epub 2020 Apr 10. No abstract available.

    PubMed 32283124
  • Marijon E, Karam N, Jost D, Perrot D, Frattini B, Derkenne C, Sharifzadehgan A, Waldmann V, Beganton F, Narayanan K, Lafont A, Bougouin W, Jouven X. Out-of-hospital cardiac arrest during the COVID-19 pandemic in Paris, France: a population-based, observational study. Lancet Public Health. 2020 Aug;5(8):e437-e443. doi: 10.1016/S2468-2667(20)30117-1. Epub 2020 May 27.

    PubMed 32473113
  • Alshahrani NS, Hartley A, Howard J, Hajhosseiny R, Khawaja S, Seligman H, Akbari T, Alharbi BA, Bassett P, Al-Lamee R, Francis D, Kaura A, Kelshiker MA, Peters NS, Khamis R. Randomized Trial of Remote Assessment of Patients After an Acute Coronary Syndrome. J Am Coll Cardiol. 2024 Jun 11;83(23):2250-2259. doi: 10.1016/j.jacc.2024.03.398. Epub 2024 Apr 6.

    PubMed 38588928

Questions about this trial

What is this clinical trial studying?

A study testing Active Arm in people with Cardiovascular Diseases and Acute Coronary Syndrome, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Hospital Readmission at 6 Months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05015634, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.

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