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Impact of a cardiac rehabilitation program versus coronary revascularization in patients with stable coronary artery disease

Impact of a cardiac rehabilitation program versus coronary revascularization in patients with stable coronary artery disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24082
Enrollment
216
Registered
2021-06-14
Start date
2021-12-01
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable angina pectoris

Interventions

A 12-month cardiac rehabilitation program (PRO-FIT) aiming at angina relief and sustainable behavioural change for long-lasting improvement in cardiovascular health. PRO-FIT will consist of multiple l

Sponsors

Maxima Medisch Centrum
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - A diagnosis of SAP with residual angina symptoms after OMT - Established ischemia (assessed by SPECT, PET, Stress ultrasound, CMR, or cycle ergometry) - Access to a personal computer, laptop or tablet with Internet connectivity at home. - Access to a mobile phone with short message service (SMS) functionality to login to the web application with two-factor authentication.

Exclusion criteria

Exclusion criteria: An echocardiography and coronary angiography (usual care group) or coronary computed tomography (CT)-angiography (CR group) will be performed to exclude high-risk patients with a reduced left ventricular function (i.e. left ventricular ejection fraction <35%). After randomisation patients will also be screened for stenosis of the left main coronary artery through computed tomography (intervention group) or coronary angiogram (control group). For these patients previous work revealed the potential prognostic benefit of revascularization, in terms of mortality, also supported by latest guidelines on myocardial revascularization with a class 1A indication for revascularization. Other exclusion criteria include: 1. PCI or CABG in the past year 2. Acute coronary syndrome in past 2 months 3. Angina symptoms at rest or rapidly progressive (i.e. unstable angina) 4. Ischemic threshold <50 watts 5. New-York Heart Association class III-IV heart failure symptoms 6. Advanced chronic kidney failure (i.e. estimated Glomerular Filtration rate <30ml/min) 7. Severe ventricular arrhythmia or exercise-induced arrythmia at baseline testing 8. A comorbidity precluding exercise training (e.g. orthopaedic, neurological or cognitive conditions) or other contra-indications for exercise training.

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the quantity of angina symptoms (evaluated by the Seattle Angina Questionnaire (SAQ-7)) following the 12-month intervention.

Secondary

MeasureTime frame
Secondary outcomes include cost-effectiveness, the ischemic threshold during exercise, cardiovascular events, quality of life, fitness, cardiovascular health and psychosocial wellbeing.

Contacts

Public ContactIris de Koning

Radboudumc

Iris.deKoning@radboudumc.nl0657121219

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)