Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy

Phase

N/A

Condition

Heart Defect

Congestive Heart Failure

Chest Pain

Treatment

N/A

Clinical Study ID

NCT04942977

TSB2014

484/14/EC

Ages 18-72
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 electricalischaemia.
Age equal to or less than 72 years.

Exclusion

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 branchblock.
Wolf-Parkinson-White syndrome.
Fixed rate pacing.
Severe anaemia.
Psychoneurotic disorders.
Neuromuscular, musculoskeletal and arthritic disorders that may limit activity. maylimit activity.

Study Design

May 28, 2019

December 07, 2020

Study 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.

Connect with a study center

Ernesto Dalli Peydró
Valencia, 46008
Spain
Site Not Available
Hospital Politécnico Universitario La Fe
Valencia, 46008
Spain
Site Not Available

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