Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy

Catcronic Salut

Status: Completed

Conditions: ST-segment Elevation Myocardial Infarction (STEMI); Non-ST-Segment Elevation Myocardial Infarction (NSTEMI); Angina, Unstable

Treatments: Device: telemonitoring; Other: Centre-based cardiac rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04942977

484/14/EC (Other Identifier)

TSB2014

Details and patient eligibility

About

Cardiac rehabilitation after an acute coronary syndrome is recognised in the latest guidelines and recommendations published by the major scientific societies as a class I indication. Despite this evidence, the number of patients entering such programmes in Europe is still around 30%. The present study aims to validate a new comprehensive Telerehabilitation System to provide support for cardiac rehabilitation, to optimize it and to test its usefulness in terms of improving adherence to physical exercise and cardiovascular risk parameters.

Full description

To validate this approach, a clinical trial was designed to compare a 10-month program of cardiac telerehabilitation with a conventional 8-week centre-based cardiac rehabilitation. Seventy patients will be randomized 1:1 to cardiac telemonitoring or centre-based cardiac rehabilitation. The characteristics of the interventions do not allow the study to be blinded to the patient or the professional. However, the analyses, stress tests and questionaires will be carried out in a masked form without the assigned group being identified by the researchers carrying out the examinations. Assessment for primary and main secondary outcomes will be performed at baseline and at ten months of follow-up, and will include self-reported physical activity (IPAQ), VO2max, blood test, general emotional distress, Adherence to the Mediterranean Diet, quality of life, vital signs, returning to work. The hypothesis is that patients randomised to prolonged telemonitoring will demonstrate higher levels of physical activity at 10-month follow-up, compared to patients in the centre-based cardiac rehabilitation programme, as well other positive changes in the cardiovascular risk profile.

Enrollment: 67 patients

Sex: All

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Patients after uncomplicated acute coronary syndrome of both sexes.
• Patients completing a maximal or symptom-limited CPET without angina or electrical ischaemia.
• Age equal to or less than 72 years.

Exclusion criteria

• Refusal of informed consent
• Advanced biological age.
• Kidney failure (GFR < 30ml/min/1.73 m2).
• Liver failure (GOT >2 times normal value).
• Ejection fraction less than 50%.
• Uncontrolled blood pressure (>140/90 mmHg).
• Uncontrolled heart failure.
• Dissecting aortic aneurysm.
• Uncontrolled ventricular tachycardia or other dangerous ventricular arrhythmias.
• Aortic or mitral valve disease.
• Recent systemic or pulmonary embolism.
• Active or recent thrombophlebitis.
• Acute infectious diseases.
• Uncontrolled supraventricular arrhythmias or tachycardia.
• Repeated or frequent ventricular ectopic activity.
• Moderate pulmonary hypertension.
• Ventricular aneurysm.
• Uncontrolled diabetes, thyrotoxicosis, myxedema,
• Conduction disorders such as: complete atrioventricular block. Left bundle branch block.
• Wolf-Parkinson-White syndrome.
• Fixed rate pacing.
• Severe anaemia.
• Psychoneurotic disorders.
• Neuromuscular, musculoskeletal and arthritic disorders that may limit activity. may limit activity.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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67 participants in 2 patient groups

Cardiac tele-rehabilitation

Experimental group

Description:

Patients in the Intervention Group will come to the hospital 4 times during two consecutive weeks, undergoing physical exercise sessions and the same educational talks as in the control group. Subsequently, they will follow the scheduled physical activities and adherence to the risk factor management according to individualised guidelines in their App, until the end of the study period. All data generated are recorded on the professional website. The degree of compliance with the objectives set is monitored by means of 7 coloured icons, which vary according to the target achievement.

Treatment:

Device: telemonitoring

Centre-based cardiac rehabilitation

Active Comparator group

Description:

Patients in the control group will come to the hospital 16 times during eight weeks for cycling and muscle strengthening exercises. Educational talks will be given. At the end of the hospital phase, a conventional outpatient follow-up by primary care and the corresponding specialist will be carried out.

Treatment:

Other: Centre-based cardiac rehabilitation