Acute Hemodynamic and Biological Effects of ECP and Exercise

December 11, 2013 updated by: Christian Seiler, University Hospital Inselspital, Berne

Acute Cardiovascular Effects of External Counterpulsation (ECP) in Comparison With Physical Exercise in Healthy Individuals

The purpose of this study in humans with stable coronary artery disease (CAD) treatable by percutaneous intervention (PCI) is to evaluate the efficacy of Enhanced External Counterpulsation (EECP) with regard to coronary collateral growth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years, written informed consent to participate in the study

Exclusion Criteria:

  • 1. Pregnancy (serum β-HCG<2 IU/l for all female volunteers)

Baseline History:

  1. Endurance exercise 5 days before and the days between the exams
  2. History of cardiovascular disease or surgery, including arterial hypertension, Raynaud phenomenon, recurrent migraine, or any cardiac rhythm disorder
  3. History of metabolic disorder, particularly diabetes mellitus
  4. History of respiratory, renal, hepatic or cerebral disease
  5. Allergic reactions to Luminity or its components
  6. Cardiovascular medication
  7. Illness characterized by acute phase response
  8. Anaemia with haemoglobin levels < 110 g/L

Baseline Physical Examination:

1. Peripheral artery disease

Baseline Echocardiogram:

  1. Valvular heart disease
  2. Aortic aneurysm (any abnormality of ascending aorta, aortic arch or descending aorta)
  3. Intra- or extracardiac shunt
  4. Systolic or diastolic left ventricular (LV) dysfunction
  5. LV-hypertrophy
  6. Pulmonary arterial hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: half supine bicycle Exercise
60 minutes of half supine bicycle exercise with submaximal workload
Other: Hemodynamic and biological measurements
by MCE, PWA, Doppler, Multiplex, FACS
Active Comparator: ECP
90 minutes of ECP
Other: Hemodynamic and biological measurements
by MCE, PWA, Doppler, Multiplex, FACS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Myocardial Blood Flow (MBF) measurement by Myocardial Contrast Echocardiography (MCE)
Time Frame: During ECP respectively Bicycle Exercise, expected to be on average 90 minutes
During ECP respectively Bicycle Exercise, expected to be on average 90 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Puls Wave Velocity Analysis
Time Frame: At baseline & post intervention, expected to be on average 90 minutes
At baseline & post intervention, expected to be on average 90 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Stefano de Marchi, MD, University of Bern
  • Principal Investigator: Stefano Rimoldi, MD, University of Bern
  • Study Director: Christian Seiler, MD, University of Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

April 5, 2011

First Submitted That Met QC Criteria

December 11, 2013

First Posted (Estimate)

December 17, 2013

Study Record Updates

Last Update Posted (Estimate)

December 17, 2013

Last Update Submitted That Met QC Criteria

December 11, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 177/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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