Clinical trial NCT01209637: Impact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable CAD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stable Coronary Artery Disease
Keywords: stable coronary artery disease
significant coronary stenosis
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2010-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: coronary collateral blod flow
timeFrame: 4 weeks
Secondary outcomes:
measure: plaque composition within the coronary artery
timeFrame: 4 weeks
measure: MACCE
timeFrame: 4 week, 6 months, 12 months
measure: atherosclerosis parameter within the laboratory
timeFrame: 4 weeks, 3, 6, 12 months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Heart Center Leipzig- University Leipzig
Study officials:
affiliation: Heart Center Leipzig- University Leipzig
name: Sven Möbius-Winkler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mobius-Winkler S, Uhlemann M, Adams V, Sandri M, Erbs S, Lenk K, Mangner N, Mueller U, Adam J, Grunze M, Brunner S, Hilberg T, Mende M, Linke AP, Schuler G. Coronary Collateral Growth Induced by Physical Exercise: Results of the Impact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable Coronary Artery Disease (EXCITE) Trial. Circulation. 2016 Apr 12;133(15):1438-48; discussion 1448. doi: 10.1161/CIRCULATIONAHA.115.016442. Epub 2016 Mar 15.
citation: Uhlemann M, Adams V, Lenk K, Linke A, Erbs S, Adam J, Thiele H, Hilberg T, Gutberlet M, Grunze M, Schuler GC, Mobius-Winkler S. Impact of different exercise training modalities on the coronary collateral circulation and plaque composition in patients with significant coronary artery disease (EXCITE trial): study protocol for a randomized controlled trial. Trials. 2012 Sep 14;13:167. doi: 10.1186/1745-6215-13-167.