Impact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable CAD

Study Overview
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Brief Summary
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Exercise training in patients with coronary artery disease is able to correct several risk factors. Furthermore endothelial function can be improved. There are some hinds for improved collateral circulation after exercise training, nevertheless there is no study showing significant improvement/ increase in coronary collaterals. This might be due to technique of collateral measurement. Therefore we conduct a study were coronary blod flow before and after 4 weeks of exercise training were measured.

Official Title
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Impact of Intensive Exercise Training Compared to Inactive Controls on Coronary Collateral Circulation and Plaque Composition in Patients With Significant Stable Coronary Artery Disease

Conditions
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Stable Coronary Artery Disease

Intervention / Treatment
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* Behavioral: exercise training
* Behavioral: Intensive exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stable CAD min.1 coronary artery stenosis >50% patient is symptomatic ( CCS 1-3)or has documented myocardial ischemia during stress test angina threshold >75 Watt informed consent Exclusion Criteria: Age <18 oder >75 akut coronary syndrome within 2 weeks LV-EF < 40 % significant valve diseases reduced patient compliance muscular disorder bronchial asthma or COLD stadium III and IV

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>standard care of coronary artery diseases incl. recommended home based exercise 3x/week | |
| Active Comparator: Exercise training<br>exercise training for 4 weeks at 70% of ischemia free individual threshold within a rehabilitation care center | Behavioral: exercise training<br>* exercise training min. 4 times a day for at least 30 min<br>|
| Active Comparator: intensive exercise training<br>intensive exercise training incl. interval training | Behavioral: Intensive exercise training<br>* Intensive exercise training for 4 times / day incl. interval training at 95% individual threshold<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coronary collateral blod flow |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plaque composition within the coronary artery | plaque composition measured by virtual histology intravascular ultrasound | 4 weeks | 
| MACCE | major cardiovascular events (death, myocardial infarction, stroke, TIA, coronary revascularisation, hospitalisation) | 4 week, 6 months, 12 months | 
| atherosclerosis parameter within the laboratory | e.g. wie hs-CRP, HDL, LDL, ges. Cholesterin, Triglyceride, Zytokine, Adipokine, Endocannaboide | 4 weeks, 3, 6, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stable coronary artery disease, significant coronary stenosis