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

Sponsor

University of Leipzig (Other)

Overall Status

Completed

CT.gov ID

NCT01209637

Collaborator

(none)

Enrollment

Location

Arms

33.1

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stable Coronary Artery Disease	Behavioral: exercise training Behavioral: Intensive exercise training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

coronary collateral blod flow [4 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Heart Center Leipzig- University Leipzig	Leipzig		Germany	04289

Sponsors and Collaborators

University of Leipzig

Investigators

Principal Investigator: Sven Möbius-Winkler, MD, Heart Center Leipzig- University Leipzig

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sven Möbius-Winkler, PI, University of Leipzig

ClinicalTrials.gov Identifier:

NCT01209637

Other Study ID Numbers:

SMW 04

First Posted:

Sep 27, 2010

Last Update Posted:

Oct 26, 2016

Last Verified:

Oct 1, 2016

Keywords provided by Sven Möbius-Winkler, PI, University of Leipzig

stable coronary artery disease

significant coronary stenosis

Additional relevant MeSH terms:

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Study Results

No Results Posted as of Oct 26, 2016