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Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

dynamic physical exercise

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring CAD, prompt physical exercise, collateral function

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age more than or 18 years old
1- to 3-vessel coronary artery disease (CAD)
Stable angina pectoris
At least 1 stenotic lesion suitable for PCI
Negative Allen-test
Written informed consent to participate in the study

Exclusion Criteria:

Patients admitted as emergencies
Acute myocardial infarction
Unstable CAD
Q-wave myocardial infarction in the area undergoing CFI measurement
CAD treated best by CABG
Severe valve disease
Pregnancy

Sites / Locations

University Hospital Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

rest first

exercise first

Arm Description

rest first, cfi, exercise, cfi

ex first

Outcomes

Primary Outcome Measures

Change of collateral flow index (CFI, no unit) during exercise (E) compared to CFI at rest (R).

Secondary Outcome Measures

Correlation of collateral flow index change and maximal workload.

Full Information

NCT ID

NCT00947050

First Posted

July 24, 2009

Last Updated

October 25, 2010

Sponsor

Insel Gruppe AG, University Hospital Bern

Collaborators

Swiss National Science Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00947050

Brief Title

Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise

Official Title

Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Insel Gruppe AG, University Hospital Bern

Collaborators

Swiss National Science Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study in humans with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate if dynamic physical exercise leads to an instantaneous improvement of coronary collateral function.

Detailed Description

The existence of coronary collateral vessels and their benefit against cardiac events have been recognized for many years, but their functional capacity in response to physical exercise has partially remained elusive. Via endothelial shear stress, the fundamental stimulus for collateral development, exercise theoretically leads to collateral vasodilation and recruitment by an increase in heart rate and blood pressure during exercise. Moreover, the phenomenon of "walking through angina" indicates that collateral function and physical activity are related and their interaction is of clinical relevance. The purpose of the present study in humans with stable coronary artery disease was to assess the instantaneous response of coronary collateral function to dynamic physical exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

CAD, prompt physical exercise, collateral function

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

rest first

Arm Type

Active Comparator

Arm Description

rest first, cfi, exercise, cfi

Arm Title

exercise first

Arm Type

Active Comparator

Arm Description

ex first

Intervention Type

Other

Intervention Name(s)

dynamic physical exercise

Other Intervention Name(s)

rest first, ex first

Intervention Description

dynamic supine bicycle exercise for 6 minutes

Primary Outcome Measure Information:

Title

Change of collateral flow index (CFI, no unit) during exercise (E) compared to CFI at rest (R).

Time Frame

6 minutes

Secondary Outcome Measure Information:

Title

Correlation of collateral flow index change and maximal workload.

Time Frame

6 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age more than or 18 years old 1- to 3-vessel coronary artery disease (CAD) Stable angina pectoris At least 1 stenotic lesion suitable for PCI Negative Allen-test Written informed consent to participate in the study Exclusion Criteria: Patients admitted as emergencies Acute myocardial infarction Unstable CAD Q-wave myocardial infarction in the area undergoing CFI measurement CAD treated best by CABG Severe valve disease Pregnancy

Overall Study Officials: