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

Stable Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209637
• Other study ID #: SMW 04
• Status: Completed
• Phase: N/A
• First received: September 24, 2010
• Last updated: October 25, 2016
• Start date: March 2010
• Est. completion date: December 2012

Study information

• Verified date: October 2016
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Stable Coronary Artery Disease

Intervention

Behavioral:
• exercise training
exercise training min. 4 times a day for at least 30 min
• Intensive exercise training
Intensive exercise training for 4 times / day incl. interval training at 95% individual threshold

Locations

Country	Name	City	State
Germany	Heart Center Leipzig- University Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	coronary collateral blod flow		4 weeks	No
Secondary	plaque composition within the coronary artery	plaque composition measured by virtual histology intravascular ultrasound	4 weeks	No
Secondary	MACCE	major cardiovascular events (death, myocardial infarction, stroke, TIA, coronary revascularisation, hospitalisation)	4 week, 6 months, 12 months	Yes
Secondary	atherosclerosis parameter within the laboratory	e.g. wie hs-CRP, HDL, LDL, ges. Cholesterin, Triglyceride, Zytokine, Adipokine, Endocannaboide	4 weeks, 3, 6, 12 months	No