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Clinical Trials/NL-OMON24082
NL-OMON24082
Not yet recruiting
Not Applicable

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

Maxima Medisch Centrum0 sites216 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
<p>Stable angina pectoris</p>
Sponsor
Maxima Medisch Centrum
Enrollment
216
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Maxima Medisch Centrum

Eligibility 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

  • 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.

Outcomes

Primary Outcomes

Not specified

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