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OpenTrials
Completed

NCT Number: NCT00414297

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bern University Hospital

Bern, 3010, Switzerland

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECP Therapy

Device

application of ECP Therapy to CAD Patients

Primary outcomes

  1. Collateral flow index (CFI)

    Time frame: 21 days

  2. Coronary collateral resistance (Rcoll)

    Time frame: 21 days

Secondary outcomes

  1. Myocardial perfusion reserve

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Dec 21, 2006
Registry last updated
Oct 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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