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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of Leipzig.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sven Möbius-Winkler, University of Leipzig
ClinicalTrials.gov Identifier:
NCT01209637
First received: September 24, 2010
Last updated: September 2, 2011
Last verified: September 2011

September 24, 2010
September 2, 2011
March 2010
December 2011   (final data collection date for primary outcome measure)
coronary collateral blod flow [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01209637 on ClinicalTrials.gov Archive Site
  • plaque composition within the coronary artery [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    plaque composition measured by virtual histology intravascular ultrasound
  • MACCE [ Time Frame: 4 week, 6 months, 12 months ] [ Designated as safety issue: Yes ]
    major cardiovascular events (death, myocardial infarction, stroke, TIA, coronary revascularisation, hospitalisation)
  • atherosclerosis parameter within the laboratory [ Time Frame: 4 weeks, 3, 6, 12 months ] [ Designated as safety issue: No ]
    e.g. wie hs-CRP, HDL, LDL, ges. Cholesterin, Triglyceride, Zytokine, Adipokine, Endocannaboide
Same as current
Not Provided
Not Provided
 
Impact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable CAD
Impact of Intensive Exercise Training Compared to Inactive Controls on Coronary Collateral Circulation and Plaque Composition in Patients With Significant Stable Coronary Artery Disease

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Stable Coronary Artery Disease
  • Behavioral: exercise training
    exercise training min. 4 times a day for at least 30 min
  • Behavioral: Intensive exercise training
    Intensive exercise training for 4 times / day incl. interval training at 95% individual threshold
  • No Intervention: control
    standard care of coronary artery diseases incl. recommended home based exercise 3x/week
  • Active Comparator: Exercise training
    exercise training for 4 weeks at 70% of ischemia free individual threshold within a rehabilitation care center
    Intervention: Behavioral: exercise training
  • Active Comparator: intensive exercise training
    intensive exercise training incl. interval training
    Intervention: Behavioral: Intensive exercise training
Uhlemann M, Adams V, Lenk K, Linke A, Erbs S, Adam J, Thiele H, Hilberg T, Gutberlet M, Grunze M, Schuler GC, Möbius-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Germany
 
NCT01209637
SMW 04
No
Sven Möbius-Winkler, University of Leipzig
University of Leipzig
Not Provided
Principal Investigator: Sven Möbius-Winkler, MD Heart Center Leipzig- University Leipzig
University of Leipzig
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP