Clinical trial NCT04942977: Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy
Official title: Prevention and Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angina, Unstable
Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)
ST-segment Elevation Myocardial Infarction (STEMI)
Keywords: mobile health
monitoring
cardiac rehabilitation
telerehabilitation
secondary prevention
Lead sponsor: Catcronic Salut SL
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase III clinical trial, feasibility, controlled and randomized, with two arms: cardiac telerehabilitation (intervention group) and centre-based cardiac rehabilitation (control group)
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical activity derived from the International Physical Activity questionnaire (IPAQ)
timeFrame: 10 months
Secondary outcomes:
measure: Maximal oxygen uptake
timeFrame: 10 months
measure: Maximal heart rate
timeFrame: 10 months
measure: Exercise time
timeFrame: 10 months
measure: Lipid parameters
timeFrame: 10 months
measure: Glycosylated haemoglobin
timeFrame: 10 months
measure: Weight
timeFrame: 4 and 10 months
measure: Waist circumference
timeFrame: 4 and 10 months
measure: Visceral fat
timeFrame: 4 and 10 months
measure: energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire
timeFrame: 10 months
measure: High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire
timeFrame: 10 months
measure: Total score of Adherence to Mediterranean Diet obtained from the Prevention with Mediterranean Diet questionnaire (PREDIMED).
timeFrame: 10 months
measure: High level of Adherence to Mediterranean Diet obtained from the Prevention with Mediterranean Diet questionnaire (PREDIMED)
timeFrame: 10 months
measure: Global score of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 10 months
measure: Anxiety subscale of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 10 months
measure: Depression subscale of Emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 10 months
measure: Global index of the health-related quality of life obtained from the European Quality of Life questionnaire (EuroQol-5D)
timeFrame: 10 months
measure: Health status obtained from the European Quality of Life questionnaire (EuroQol-5D)
timeFrame: 10 months
measure: smoking cessation
timeFrame: 10 months
measure: Time to start the rehabilitation programme after discharge from hospital
timeFrame: 10 months
measure: Returning to work
timeFrame: 10 months
measure: Pulse wave velocity
timeFrame: 10 months
measure: User's experience from the System Usability Scale (SUS) score
timeFrame: 10 months
measure: Cost-effectiveness analysis
timeFrame: 10 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Ernesto Dalli Peydró
city: Valencia
country: Spain
facility: Hospital Politécnico Universitario La Fe
Study officials:
affiliation: Hospital Arnau de Vilanova. Valencia
name: Ernesto Dalli Peydró, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ambrosetti M, Abreu A, Corra U, Davos CH, Hansen D, Frederix I, Iliou MC, Pedretti RFE, Schmid JP, Vigorito C, Voller H, Wilhelm M, Piepoli MF, Bjarnason-Wehrens B, Berger T, Cohen-Solal A, Cornelissen V, Dendale P, Doehner W, Gaita D, Gevaert AB, Kemps H, Kraenkel N, Laukkanen J, Mendes M, Niebauer J, Simonenko M, Zwisler AO. Secondary prevention through comprehensive cardiovascular rehabilitation: From knowledge to implementation. 2020 update. A position paper from the Secondary Prevention and Rehabilitation Section of the European Association of Preventive Cardiology. Eur J Prev Cardiol. 2021 May 14;28(5):460-495. doi: 10.1177/2047487320913379.
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citation: Reibis R, Salzwedel A, Abreu A, Corra U, Davos C, Doehner W, Doherty P, Frederix I, Hansen D, Christine Iliou M, Vigorito C, Voller H; Secondary Prevention and Rehabilitation of the European Association of Preventive Cardiology (EAPC). The importance of return to work: How to achieve optimal reintegration in ACS patients. Eur J Prev Cardiol. 2019 Sep;26(13):1358-1369. doi: 10.1177/2047487319839263. Epub 2019 Apr 10.
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