The Effect of Enhanced External Counter Pulsation on Left Ventricular Systolic and Diastolic Function

April 27, 2010 updated by: Herning Hospital

Enhanced external counter pulsation (EECP) is a procedure performed on patients with ischemic heart disease. The treatment improves physical capacity and relieves angina pectoris. It is suitable for patients with persistent angina pectoris despite and for patients not amendable for coronary revascularization. Some studies demonstrate a relationship between diastolic and systolic blood pressure ratio (d/s ratio) and the effect of EECP.

The aim of the investigators study is to understand the effect of EECP on left ventricular systolic and diastolic function assessed by trans-thoracic echocardiography (TTE).

Hypothesis: EECP improves left ventricular systolic and diastolic function. There is a relationship between d/s ratio and aortic arterial stiffness EECP improves left ventricular diastolic function Standard TTE would be performed prior the EECP procedure, which lasts 60 min., and repeated every 15 minutes. Moreover the investigators would measure pulse wave velocity, a measure of aortic arterial stiffness, in order to investigate the relationship between the d/s ratio and arterial stiffness.

The patients would be recruited among former study patients who have undergone EECP before. 20 patients with the best acoustic conditions would be selected and invited to enroll into the study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

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

  • Denmark
      • Herning, Denmark, 7400
        • Regionshospitalet Herning

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Angina pectoris, CCS-class 2-4
  • Reversal ischemia
  • Pathological coronary angiogram without the possibility of revascularization
  • Sinus rhythm

Exclusion Criteria:

  • Cancer
  • Dementia
  • Pregnancy
  • Blood pressure > 180/110
  • Severe valvular disease
  • Ejection fraction < 25%
  • Acute coronary syndrome the last 3 months
  • History of aortic aneurism
  • Pacemaker
  • Diabetes mellitus
  • Cardiac arrythmia that prevents the EECP procedure
  • Bleeding
  • Active venous thrombosis

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced external counter pulsation
One session of enhanced external counter pulsation (60 minutes)
Device: Enhanced external counter pulsation
While an individual is undergoing ECP, they have pneumatic stockings (also known as cuffs) on their legs and are connected to telemetry monitors that monitor their heart rate and rhythm.The cuffs should ideally inflate at the beginning of diastole and deflate at the beginning of systole. During the inflation portion of the cycle, the calf cuffs inflate first, then the lower thigh cuffs and finally the upper thigh cuffs. Inflation is controlled by a pressure monitor, and the cuffs are inflated to about 300 mmHg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular longitudinal strain
Time Frame: 60 minutes
A measure of left ventricular shortening during systole assessed by speckle tracking with trans thoracic echocardiography
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse wave velocity
Time Frame: 60 minutes
Pulse wave velocity is a measure of aortic arterial stiffness. The outcome is the relationhip between pulse wave velocity and d/s ratio
60 minutes
left ventricular diastolic function
Time Frame: 60 minutes
EECP reduces left ventricular after load and increases cardiac output. Left ventricular diastolic function is assessed by tissue Doppler imaging
60 minutes

Collaborators and Investigators

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

Sponsor

Herning Hospital

Investigators

  • Principal Investigator: Ashkan Eftekhari, MD PhD, Regionshospitalet Herning / Dept. Pharmacology Aarhus University
  • Study Chair: Ole May, MD PhD, Herning Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2010

Primary Completion (Anticipated)

November 1, 2010

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

April 26, 2010

First Submitted That Met QC Criteria

April 27, 2010

First Posted (Estimate)

April 28, 2010

Study Record Updates

Last Update Posted (Estimate)

April 28, 2010

Last Update Submitted That Met QC Criteria

April 27, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EECP-VV

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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