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

Primary Purpose

Stable Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
exercise training
Intensive exercise training
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Coronary Artery Disease focused on measuring stable coronary artery disease, significant coronary stenosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Heart Center Leipzig- University Leipzig

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

control

Exercise training

intensive exercise training

Arm Description

standard care of coronary artery diseases incl. recommended home based exercise 3x/week

exercise training for 4 weeks at 70% of ischemia free individual threshold within a rehabilitation care center

intensive exercise training incl. interval training

Outcomes

Primary Outcome Measures

coronary collateral blod flow

Secondary Outcome Measures

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

Full Information

First Posted
September 24, 2010
Last Updated
October 25, 2016
Sponsor
University of Leipzig
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1. Study Identification

Unique Protocol Identification Number
NCT01209637
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Coronary Artery Disease
Keywords
stable coronary artery disease, significant coronary stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
standard care of coronary artery diseases incl. recommended home based exercise 3x/week
Arm Title
Exercise training
Arm Type
Active Comparator
Arm Description
exercise training for 4 weeks at 70% of ischemia free individual threshold within a rehabilitation care center
Arm Title
intensive exercise training
Arm Type
Active Comparator
Arm Description
intensive exercise training incl. interval training
Intervention Type
Behavioral
Intervention Name(s)
exercise training
Intervention Description
exercise training min. 4 times a day for at least 30 min
Intervention Type
Behavioral
Intervention Name(s)
Intensive exercise training
Intervention Description
Intensive exercise training for 4 times / day incl. interval training at 95% individual threshold
Primary Outcome Measure Information:
Title
coronary collateral blod flow
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
plaque composition within the coronary artery
Description
plaque composition measured by virtual histology intravascular ultrasound
Time Frame
4 weeks
Title
MACCE
Description
major cardiovascular events (death, myocardial infarction, stroke, TIA, coronary revascularisation, hospitalisation)
Time Frame
4 week, 6 months, 12 months
Title
atherosclerosis parameter within the laboratory
Description
e.g. wie hs-CRP, HDL, LDL, ges. Cholesterin, Triglyceride, Zytokine, Adipokine, Endocannaboide
Time Frame
4 weeks, 3, 6, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Möbius-Winkler, MD
Organizational Affiliation
Heart Center Leipzig- University Leipzig
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Center Leipzig- University Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26979085
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.
Results Reference
derived
PubMed Identifier
22974129
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.
Results Reference
derived

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

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