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Angina, UnstableNCT04942977

Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy

A study testing telemonitoring and Centre-based cardiac rehabilitation in people with Angina, Unstable and Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), run by Catcronic Salut SL at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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%. Read more about this study

Who is it for?
Ages 18 to 72 years
What is being tested?
telemonitoring and Centre-based cardiac rehabilitation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
2 sitesSpain
Study dates
28 May 2019to 7 Dec 2020
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 to 72 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 24Show fewer
  • 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 locations and contacts

2 sites in 1 country.

Spain2 sites

  • Ernesto Dalli Peydró

    Valencia, 46008

  • Hospital Politécnico Universitario La Fe

    Valencia, 46008

Other trials in Spain

About this study

Official title: Prevention and 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.

Read the 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.

Being tested
telemonitoring, Centre-based cardiac rehabilitation
Keywords
mobile health, monitoring, cardiac rehabilitation, telerehabilitation, secondary prevention
Medical subject headings
Angina, Unstable, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • telemonitoringDevice

    The system consists of the following elements:

    1. 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.
    1. 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 rehabilitationOther

    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.

Study groups in NCT04942977
Study groupRoleWhat they receive
Cardiac tele-rehabilitationExperimentalPatients 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.
Receives: Device: telemonitoring
Centre-based cardiac rehabilitationActive comparatorPatients 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.
Receives: Other: Centre-based cardiac rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 10 months

Secondary outcomes (23)

  1. Maximal oxygen uptake

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

    Measured: 10 months

  2. Maximal heart rate

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

    Measured: 10 months

  3. Exercise time

    stress test duration (minutes)

    Measured: 10 months

  4. Lipid parameters

    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

    Measured: 10 months

  5. Glycosylated haemoglobin

    Percentage

    Measured: 10 months

  6. Weight

    Kg

    Measured: 4 and 10 months

  7. Waist circumference

    waist circumference change (cm)

    Measured: 4 and 10 months

  8. Visceral fat

    Percentage

    Measured: 4 and 10 months

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

    Kcal/week

    Measured: 10 months

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

    Percentage

    Measured: 10 months

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

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

    Measured: 10 months

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

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

    Measured: 10 months

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

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

    Measured: 10 months

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

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

    Measured: 10 months

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

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

    Measured: 10 months

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

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

    Measured: 10 months

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

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

    Measured: 10 months

  18. smoking cessation

    percentage

    Measured: 10 months

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

    days

    Measured: 10 months

  20. Returning to work

    days

    Measured: 10 months

  21. Pulse wave velocity

    m/s

    Measured: 10 months

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

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

    Measured: 10 months

  23. Cost-effectiveness analysis

    net cost divided by changes in health outcomes

    Measured: 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2021
  2. Study start28 May 2019
  3. Primary completion7 Dec 2020
  4. Study completion7 Dec 2020

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase III clinical trial, feasibility, controlled and randomized, with two arms: cardiac telerehabilitation (intervention group) and centre-based cardiac rehabilitation (control group)
Masking
Single blind
Who is masked
Care provider
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04942977
Sponsor's protocol ID
TSB2014
Other IDs
484/14/EC
Status last verified
Jun 2021
First submitted
12 Jun 2021
Last updated
29 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33611446

  • Thomas RJ, Beatty AL, Beckie TM, Brewer LC, Brown TM, Forman DE, Franklin BA, Keteyian SJ, Kitzman DW, Regensteiner JG, Sanderson BK, Whooley MA. Home-Based Cardiac Rehabilitation: A Scientific Statement From the American Association of Cardiovascular and Pulmonary Rehabilitation, the American Heart Association, and the American College of Cardiology. Circulation. 2019 Jul 2;140(1):e69-e89. doi: 10.1161/CIR.0000000000000663. Epub 2019 May 13.

    PubMed 31082266

  • Frederix I, Vanhees L, Dendale P, Goetschalckx K. A review of telerehabilitation for cardiac patients. J Telemed Telecare. 2015 Jan;21(1):45-53. doi: 10.1177/1357633X14562732. Epub 2014 Dec 4.

    PubMed 25475219

  • Scherrenberg M, Falter M, Dendale P. Providing comprehensive cardiac rehabilitation during and after the COVID-19 pandemic. Eur J Prev Cardiol. 2021 May 14;28(5):520-521. doi: 10.1093/eurjpc/zwaa107. No abstract available.

    PubMed 33623986

  • 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.

    PubMed 30971111

  • Frederix I, Hansen D, Coninx K, Vandervoort P, Vandijck D, Hens N, Van Craenenbroeck E, Van Driessche N, Dendale P. Medium-Term Effectiveness of a Comprehensive Internet-Based and Patient-Specific Telerehabilitation Program With Text Messaging Support for Cardiac Patients: Randomized Controlled Trial. J Med Internet Res. 2015 Jul 23;17(7):e185. doi: 10.2196/jmir.4799.

    PubMed 26206311

Questions about this trial

What is this clinical trial studying?

A study testing telemonitoring and Centre-based cardiac rehabilitation in people with Angina, Unstable and Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), run by Catcronic Salut SL at 2 sites 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 4 inclusion and 24 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 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Physical activity derived from the International Physical Activity questionnaire (IPAQ) (time frame: 10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04942977, which also lists 6 linked publications.

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 29 Jun 2021.

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