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NCT Number: NCT04942977

Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy

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.

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Key information

Conditions

Angina, Unstable Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Non-ST Elevated Myocardial Infarction Non-ST-Segment Elevation Myocardial Infarction (NSTEMI) Pain Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction ST-segment Elevation Myocardial Infarction (STEMI) Signs and Symptoms Vascular Diseases

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ernesto Dalli Peydró, Valencia, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Telemonitoring

Device

The system consists of the following elements:

  • Professional website at the hospital, which allows:
  • To set up an individualised care plan
  • To establish the patient's risk profile and targets for improvement.
  • Long-term monitoring of the evolution of cardiovascular risk factors and events that occurred
  • Advise the patient on self-management strategies.
  • Mobile application software with the following functions:
  • Scheduled exercise sessions
  • Medication reminder
  • Measurement reminder (weight, blood pressure, heart rate, waist circumference, etc.)
  • Messages: Inbox folder for system messages and messages generated by professionals for a specific patient or video conference.
  • Training monitor: guides the patient in the performance of their exercise.
  • Access to certified health information for patients

Centre-based cardiac rehabilitation

Other

The physical activity consisted of a workout routine and aerobic cycling training. Patients are instructed to perform 150 minutes per week of moderate physical activity when the hospital phase finishes.

Primary outcomes

  1. Physical activity derived from the International Physical Activity questionnaire (IPAQ)

    Time frame: 10 months

    self-reported physical activity measured in metabolic equivalents (MET-min/week) Minimum value: 0, maximum value 19,278. Higher scores mean a better outcome.

Secondary outcomes

  1. Maximal oxygen uptake

    Time frame: 10 months

    Maximal oxygen uptake during the final 30 seconds of the cardiopulmonary exercise testing (CPET) (ml/kg/min )

  2. Maximal heart rate

    Time frame: 10 months

    Maximal heart rate at the end of the exercise testing (bpm)

  3. Exercise time

    Time frame: 10 months

    stress test duration (minutes)

  4. Lipid parameters

    Time frame: 10 months

    Total cholesterol (mg/dL), HDL cholesterol (mg/dL), LDL cholesterol (mg/dL), Non-HDL cholesterol (mg/dL), Triglycerides (mg/dL), Apolipoprotein B/Apolipoprotein A-I ratio

  5. Glycosylated haemoglobin

    Time frame: 10 months

    Percentage

  6. Weight

    Time frame: 4 and 10 months

    Kg

  7. Waist circumference

    Time frame: 4 and 10 months

    waist circumference change (cm)

  8. Visceral fat

    Time frame: 4 and 10 months

    Percentage

  9. energy expenditure obtained from the International Physical Activity questionnaire (IPAQ) questionaire

    Time frame: 10 months

    Kcal/week

  10. High level of effort obtained from the International Physical Activity questionnaire (IPAQ) questionaire

    Time frame: 10 months

    Percentage

  11. Total score of Adherence to Mediterranean Diet obtained from the Prevention with Mediterranean Diet questionnaire (PREDIMED).

    Time frame: 10 months

    Units. Minimum value: 0, maximum value: 14. Higher scores mean a better outcome.

  12. High level of Adherence to Mediterranean Diet obtained from the Prevention with Mediterranean Diet questionnaire (PREDIMED)

    Time frame: 10 months

    percentage. Minimum value: 0%, maximum value: 100%. Higher scores mean a better outcome.

  13. Global score of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)

    Time frame: 10 months

    Units. Minimum value: 0, maximum value: 14. Lower scores mean a better outcome.

  14. Anxiety subscale of emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)

    Time frame: 10 months

    Units. Minimum value: 0, maximum value: 7. Lower scores mean a better outcome.

  15. Depression subscale of Emotional distress obtained from the Hospital Anxiety and Depression Scale (HADS)

    Time frame: 10 months

    Units. Minimum value: 0, maximum value: 7. Lower scores mean a better outcome.

  16. Global index of the health-related quality of life obtained from the European Quality of Life questionnaire (EuroQol-5D)

    Time frame: 10 months

    Units. Minimum value: 0, maximum value: 1. Higher scores mean a better outcome.

  17. Health status obtained from the European Quality of Life questionnaire (EuroQol-5D)

    Time frame: 10 months

    Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome.

  18. smoking cessation

    Time frame: 10 months

    percentage

  19. Time to start the rehabilitation programme after discharge from hospital

    Time frame: 10 months

    days

  20. Returning to work

    Time frame: 10 months

    days

  21. Pulse wave velocity

    Time frame: 10 months

    m/s

  22. User's experience from the System Usability Scale (SUS) score

    Time frame: 10 months

    Units. Minimum value: 0, maximum value: 100. Higher scores mean a better outcome.

  23. Cost-effectiveness analysis

    Time frame: 10 months

    net cost divided by changes in health outcomes

Sponsors and collaborators

Lead sponsor

Catcronic Salut SL

Other

Registry information

Official study title

Prevention and Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 29, 2021
Registry last updated
Jun 29, 2021

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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