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

Primary Purpose

Cardiovascular Diseases, Acute Coronary Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Active Arm
Control Arm
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiovascular Diseases focused on measuring Myocardial infarction, Acute coronary syndrome, Telemedicine, Heart Attack

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Imperial College Healthcare NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Arm

Control Arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 11, 2021
Last Updated
March 8, 2023
Sponsor
Imperial College London
Collaborators
King Khalid University
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1. Study Identification

Unique Protocol Identification Number
NCT05015634
Brief Title
Telemedicine in High-Risk Cardiovascular Patients Post-ACS
Acronym
TELE-ACS
Official Title
Remote Acute Assessment of Patients With High Cardiovascular Risk Post-Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
King Khalid University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Acute Coronary Syndrome
Keywords
Myocardial infarction, Acute coronary syndrome, Telemedicine, Heart Attack

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A total of 338 patients will be randomised 1:1 to the 2 trial arms over 9 months.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
338 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
Intervention Type
Other
Intervention Name(s)
Active Arm
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Arm
Intervention Description
Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
Primary Outcome Measure Information:
Title
All hospital readmission rates
Description
At 6 months of follow up, compare formal admissions and not emergency room visits in intervention to control groups.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Length of stay
Description
Length of stay at 3, 6, and 9 months will be compared in both study groups.
Time Frame
9 months
Title
All-cause mortality, morbidity, and MACE.
Description
At 9 months of follow up, compare all-cause mortality, morbidity, and MACE.
Time Frame
9 months
Title
Medical intervention
Description
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.
Time Frame
9 months
Title
Emergency Department visits
Description
Any emergency department visits not requiring admission or further intervention will be compared in both study groups at 9 months of follow up.
Time Frame
9 months
Title
9 months readmission rates
Description
The readmission rates for 9 months will be compared in both study groups.
Time Frame
9 months
Title
Patient-reported quality of life
Description
Patients in both study groups will fill out a quality of life questionnaires
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramzi Y Khamis, MB ChB PhD FRCP
Phone
02075946842
Email
r.khamis@imperial.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Nasser S Alshahrani, BSEMS MSc
Phone
07496861415
Email
n.alshahrani20@imperial.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramzi Y Khamis, MB ChB PhD FRCP
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NASSER ALSHHARANI

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
28728745
Citation
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.
Results Reference
background
PubMed Identifier
31407368
Citation
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.
Results Reference
background
PubMed Identifier
25237046
Citation
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.
Results Reference
background
PubMed Identifier
28153989
Citation
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.
Results Reference
background
PubMed Identifier
31941686
Citation
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.
Results Reference
background
PubMed Identifier
25046174
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.
Results Reference
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PubMed Identifier
32283124
Citation
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.
Results Reference
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PubMed Identifier
32473113
Citation
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.
Results Reference
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Telemedicine in High-Risk Cardiovascular Patients Post-ACS

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