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External Counterpulsation (ECP) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
ECP Therapy
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring CAD, ECP, CFI, CPI, MPR

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 years old
  • 1- to 3-vessel coronary artery disease (CAD)
  • Stable angina pectoris
  • At least 1 stenotic lesion suitable for PCI within the next 4 weeks
  • No Q-wave myocardial infarction in the area undergoing CFI measurement
  • Written informed consent to participate in the study

Exclusion Criteria:

  • Patients admitted as emergencies
  • Acute myocardial infarction within the last 3 months
  • Unstable CAD
  • CAD treated best by CABG
  • Coronary stenotic lesion to be treated ad-hoc or within < 4 weeks
  • Severe valve disease
  • Pulmonary artery hypertension
  • Congestive heart failure
  • Atrial fibrillation
  • Thrombophlebitis and/or deep vein thrombosis
  • Occlusive peripheral artery disease
  • Abdominal aortic aneurysm

Sites / Locations

  • Bern University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1 ECP

2

Arm Description

active ECP Therapy

Sham ECP Treatment

Outcomes

Primary Outcome Measures

Collateral flow index (CFI)
Coronary collateral resistance (Rcoll)

Secondary Outcome Measures

Myocardial perfusion reserve

Full Information

First Posted
December 20, 2006
Last Updated
October 25, 2010
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT00414297
Brief Title
External Counterpulsation (ECP) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease
Official Title
External Counterpulsation (ECP) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

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 percutaneous coronary intervention (PCI) is to evaluate the efficacy of External Counterpulsation (ECP) with regard to the promotion of coronary collateral growth.
Detailed Description
Alternative strategies for the promotion of coronary collaterals (arteriogenesis) are a promising therapeutic alternative for at least 20% of all Patients with Coronary Artery Disease (CAD). Beside growth factors, physical exercise has been shown to improve coronary collateral function. Extracorporal Counterpulsation (ECP) mimics physical exercise in a standardized way. Before and after ECP treatment, a quantitative invasive assessment of absolute collateral flow (by calculating the CFI, i.e. Collateral Flow Index) and myocardial perfusion is performed (with calculation of the CPI, i.e. Collateral Perfusion Index and MPR, i.e. Myocardial Perfusion Reserve). The study setting is single-blinded, sham-controlled and proceptive .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CAD, ECP, CFI, CPI, MPR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 ECP
Arm Type
Active Comparator
Arm Description
active ECP Therapy
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Sham ECP Treatment
Intervention Type
Device
Intervention Name(s)
ECP Therapy
Intervention Description
application of ECP Therapy to CAD Patients
Primary Outcome Measure Information:
Title
Collateral flow index (CFI)
Time Frame
21 days
Title
Coronary collateral resistance (Rcoll)
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Myocardial perfusion reserve
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years old 1- to 3-vessel coronary artery disease (CAD) Stable angina pectoris At least 1 stenotic lesion suitable for PCI within the next 4 weeks No Q-wave myocardial infarction in the area undergoing CFI measurement Written informed consent to participate in the study Exclusion Criteria: Patients admitted as emergencies Acute myocardial infarction within the last 3 months Unstable CAD CAD treated best by CABG Coronary stenotic lesion to be treated ad-hoc or within < 4 weeks Severe valve disease Pulmonary artery hypertension Congestive heart failure Atrial fibrillation Thrombophlebitis and/or deep vein thrombosis Occlusive peripheral artery disease Abdominal aortic aneurysm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Seiler, MD, Prof.
Organizational Affiliation
University of Bern
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Steffen Gloekler, MD
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bern University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23056467
Citation
Al Kaabi A, Traupe T, Stutz M, Buchs N, Heller M. Cause or effect of arteriogenesis: compositional alterations of microparticles from CAD patients undergoing external counterpulsation therapy. PLoS One. 2012;7(10):e46822. doi: 10.1371/journal.pone.0046822. Epub 2012 Oct 8.
Results Reference
derived

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External Counterpulsation (ECP) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease

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