Acute Myocardial Infarction (AMI)TELECORNCT06807658
Cardiac Telerehabilitation Versus In-person After Acute Coronary Syndrome
A study testing Experimental: Cardiac tele-rehabilitation in people with Acute Myocardial Infarction (AMI) and Cardiac Rehabilitation, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction (AMI), Cardiac Rehabilitation
- What is being tested?
- Experimental: Cardiac tele-rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2022to 2 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- No relevant arrythmias
- Left ventricular ejection fraction >= 35%
- Functional capacity >5 METS
- Signing of the inform consent
Who cannot join
- Physical or intellectual disability that prevents patients from enrolling in a cardiac rehabilitation program
- Impossibility for digital media use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac Telerehabilitation Versus In-person After Acute Coronary Syndrome: Randomized Clinical Trial TELECOR 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
Read the detailed description
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.
- Being tested
- Experimental: Cardiac tele-rehabilitation, Other: Control, in person cardiac rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Cardiac tele-rehabilitationBehavioural
Patients will connect to their health care provider via a tele-call
Other: Control, in person cardiac rehabilitationBehavioural
Patients will attend an ambulatory cardiac rehabilitation unit
| Study group | Role | What they receive |
|---|---|---|
| Tele-rehabilitation | Experimental | Patients with a myocardial infarction candidates to a rehabilitation program, will be enrolled. The patient is guided via a face-to-face telematic call to perform the cardiac rehabilitation exercises and life style education. Receives: Behavioral: Experimental: Cardiac tele-rehabilitation |
| In person cardiac rehabilitation | Active comparator | Patients with a myocardial infarction candidates to a rehabilitation program, will be enrolled. The patient attends an in-person cardiac rehabilitation exercises and life style education at the hospital. Receives: Behavioral: Other: Control, in person cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
% patients with a positive result in the composite variable integrating different targets for secondary prevention in cardiovascular disease and lifestyle habits
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)
Measured: • (%) [Time Frame: 0-2months +- 30 days-6 months +-7days]
Secondary outcomes (9)
Adherence to cardiac rehabilitation program
% of patients adherent to cardiac rehabilitation program
Measured: 2 months +-30 day
Adherence to pharmacological treatment
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.
Measured: 0-2months +- 30 days-6 months +-7days
Quality of Life improvement
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).
Measured: 0-2months +- 30 days-6 months +-7days
Anxiety and depression
Anxiety and depression by Hospital Anxiety and Depression Scale (HADS). HAD Questionnaire:
0-42: Higher values are worse than lower values.
Measured: 0-2months +- 30 days-6 months +-7days
Satisfaction rate
Satisfaction rate with the program, Scale 0-100 (%); 0-100%: Higher values are better than lower values
Measured: 2months +- 30 days
Functional capacity
Functional capacity by cardiac stress test (METS)
Measured: 0-2months +- 30 days
Cardiac cause hospitalization
Cardiac cause hospitalization
Measured: 6 months +-7days
Emergency visits
Emergency visits
Measured: 6 months +-7days
Angioplasty revascularization procedure
Angioplasty revascularization procedure. Further coronary angiography during follow up Yes: is worse No: is better
Measured: 0-2months +- 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 Jun 2022
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807658
- Sponsor's protocol ID
- PI-21-286
- Other IDs
- PI-21-286
- Acronym
- TELECOR
- Status last verified
- Feb 2025
- First submitted
- 29 Jan 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Telerehabilitation Versus In-person After Acute Coronary Syndrome: Randomized Clinical Trial TELECOR Study
- ClinicalTrials.gov ID
- NCT06807658
- Acronym / sponsor ID
- TELECOR / PI-21-286
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-rehabilitation | Experimental | Behavioral: Experimental: Cardiac tele-rehabilitationPatients with a myocardial infarction candidates to a rehabilitation program, will be enrolled. The patient is guided via a face-to-face telematic call to perform the cardiac rehabilitation exercises and life style education. |
| In person cardiac rehabilitation | Active comparator | Behavioral: Other: Control, in person cardiac rehabilitationPatients with a myocardial infarction candidates to a rehabilitation program, will be enrolled. The patient attends an in-person cardiac rehabilitation exercises and life style education at the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Acute myocardial infarct prior to 2 months
- Killip I-II classification
- No previous myocardial infarction
- No angina pectoris
- No ischemia in complementary explorations
Key exclusion criteria (2 listed)
- Physical or intellectual disability that prevents patients from enrolling in a cardiac rehabilitation program
- Impossibility for digital media use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Cardiac tele-rehabilitationPatients will connect to their health care provider via a tele-call | Behavioural | Tele-rehabilitation |
| Other: Control, in person cardiac rehabilitationPatients will attend an ambulatory cardiac rehabilitation unit | Behavioural | In person cardiac rehabilitation |
Primary outcome
% 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 1. Blood pressure <140/90 mmHg 2. Maintaining normal weight or a 5% reduction in body weight if BMI > 25 kg/m2 3. Abdominal circumference <88 cm in women and <102 cm in men 4. LDL <50 mg/dl and a reduction of >50% in initial LDL levels 5. Smoking cessation 6. Adherence to a heart-healthy diet (PREDIMED Questionnaire* ≥7) 7. Adherence to physical activity level: 6,000-10,000 steps/day or moderate-high IPAQ** result (International Physical Activity Questionnaire)
9 secondary outcomes
Adherence to cardiac rehabilitation program
Time frame: 2 months +-30 day
Adherence to pharmacological treatment
Time frame: 0-2months +- 30 days-6 months +-7days
Quality of Life improvement
Time frame: 0-2months +- 30 days-6 months +-7days
Anxiety and depression
Time frame: 0-2months +- 30 days-6 months +-7days
Satisfaction rate
Time frame: 2months +- 30 days
Functional capacity
Time frame: 0-2months +- 30 days
Cardiac cause hospitalization
Time frame: 6 months +-7days
Emergency visits
Time frame: 6 months +-7days
Angioplasty revascularization procedure
Time frame: 0-2months +- 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Myocardial Infarction (AMI)
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Cardiac tele-rehabilitation in people with Acute Myocardial Infarction (AMI) and Cardiac Rehabilitation, run by Germans Trias i Pujol Hospital at 1 site in Spain.
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 10 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 24 Feb 2025. 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 Spain. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
% 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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2025.