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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
  Purpose

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.


Condition Intervention
Stable Coronary Artery Disease
Behavioral: exercise training
Behavioral: Intensive exercise training

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

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • coronary collateral blod flow [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Behavioral: exercise training
exercise training min. 4 times a day for at least 30 min
Active Comparator: intensive exercise training
intensive exercise training incl. interval training
Behavioral: Intensive exercise training
Intensive exercise training for 4 times / day incl. interval training at 95% individual threshold

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209637

Locations
Germany
Heart Center Leipzig- University Leipzig Recruiting
Leipzig, Germany, 04289
Contact: Sven Moebius-Winkler, MD    0049-341-0    moes@medizin.uni-leipzig.de   
Contact: Madleen Uhlemann, MD    0049-341-8650      
Principal Investigator: Sven Möbius-Winkler, MD         
Sub-Investigator: Madleen Uhlemann, MD         
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Sven Möbius-Winkler, MD Heart Center Leipzig- University Leipzig
  More Information

No publications provided by University of Leipzig

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sven Möbius-Winkler, PI, University of Leipzig
ClinicalTrials.gov Identifier: NCT01209637     History of Changes
Other Study ID Numbers: SMW 04
Study First Received: September 24, 2010
Last Updated: September 2, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University of Leipzig:
stable coronary artery disease
significant coronary stenosis

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014