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Completed

NCT Number: NCT06807658

Cardiac Telerehabilitation Versus In-person After Acute Coronary Syndrome

The purpose of this trial is to evaluate wether a cardiac Telerehabilitation programme is as effective as an in-person rehabilitation program after acute coronary syndrome in the control of cardiovascular risk factors

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Germans Trias i Pujol University Hospital

Badalona, Spain

About this study

The purpose of this trial is to evaluate wether a cardiac Telerehabilitation programme is as effective as an in-person rehabilitation program after acute coronary syndrome in the control of cardiovascular risk factors via the following variables: % patients with a positive result in the composite variable integrating different targets for secondary prevention in cardiovascular disease and lifestyle habits; Adherence to cardiac rehabilitation program; Adherence to pharmacological treatment; Quality of Life improvement ; Anxiety and depression; Satisfaction rate; Functional capacity; Cardiac cause hospitalization; Emergency visits; and Angioplasty revascularization procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute myocardial infarct prior to 2 months
  • Killip I-II classification
  • No previous myocardial infarction
  • No angina pectoris
  • No ischemia in complementary explorations
  • Normal arterial pressure response during stress test.
  • No relevant arrythmias
  • Left ventricular ejection fraction >= 35%
  • Functional capacity >5 METS
  • Signing of the inform consent

Exclusion criteria

  • Physical or intellectual disability that prevents patients from enrolling in a cardiac rehabilitation program
  • Impossibility for digital media use

Treatment and study plan

Experimental: Cardiac tele-rehabilitation

Behavioral

Patients will connect to their health care provider via a tele-call

Other: Control, in person cardiac rehabilitation

Behavioral

Patients will attend an ambulatory cardiac rehabilitation unit

Primary outcomes

  1. % patients with a positive result in the composite variable integrating different targets for secondary prevention in cardiovascular disease and lifestyle habits

    Time frame: • (%) [Time Frame: 0-2months +- 30 days-6 months +-7days]

    Variable for Cardiovascular Risk Factor Control: Composite Variable Integrating Different Targets for Secondary Prevention in Cardiovascular Disease and Lifestyle Habits

    • Blood pressure <140/90 mmHg
    • Maintaining normal weight or a 5% reduction in body weight if BMI > 25 kg/m2
    • Abdominal circumference <88 cm in women and <102 cm in men
    • LDL <50 mg/dl and a reduction of >50% in initial LDL levels
    • Smoking cessation
    • Adherence to a heart-healthy diet (PREDIMED Questionnaire* ≥7)
    • Adherence to physical activity level: 6,000-10,000 steps/day or moderate-high IPAQ** result (International Physical Activity Questionnaire)

Secondary outcomes

  1. Adherence to cardiac rehabilitation program

    Time frame: 2 months +-30 day

    % of patients adherent to cardiac rehabilitation program

  2. Adherence to pharmacological treatment

    Time frame: 0-2months +- 30 days-6 months +-7days

    Adherence to pharmacological treatment by Morinsky Green Questionnaire, Dichotomous variable: yes means adherent to treatment wich is a better score and no means non adherent to treatment wich is a worse score.

  3. Quality of Life improvement

    Time frame: 0-2months +- 30 days-6 months +-7days

    Quality of Life by EuroQol-5D questionnaire. EuroQoL-5D index (0-1) 0: Represent the worse state of Health, equivalent to death.

    1: Represents the best state of Health ( no problems in any dimension of the questionnaire).

  4. Anxiety and depression

    Time frame: 0-2months +- 30 days-6 months +-7days

    Anxiety and depression by Hospital Anxiety and Depression Scale (HADS). HAD Questionnaire:

    0-42: Higher values are worse than lower values.

  5. Satisfaction rate

    Time frame: 2months +- 30 days

    Satisfaction rate with the program, Scale 0-100 (%); 0-100%: Higher values are better than lower values

  6. Functional capacity

    Time frame: 0-2months +- 30 days

    Functional capacity by cardiac stress test (METS)

  7. Cardiac cause hospitalization

    Time frame: 6 months +-7days

    Cardiac cause hospitalization

  8. Emergency visits

    Time frame: 6 months +-7days

    Emergency visits

  9. Angioplasty revascularization procedure

    Time frame: 0-2months +- 30 days

    Angioplasty revascularization procedure. Further coronary angiography during follow up Yes: is worse No: is better

Other outcomes

  1. Cost analysis

    Time frame: 6 months +-7days

    Analyze in terms of economic cost (euros) whether there are differences between both programs ( total cost of Telerehabilitation program and total cost of in person program) Total cost includes: direct costs, indirect costs, and intangible costs.

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Registry information

Official study title

Cardiac Telerehabilitation Versus In-person After Acute Coronary Syndrome: Randomized Clinical Trial TELECOR Study

Acronym: TELECOR

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 4, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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