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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Herning Hospital
ClinicalTrials.gov Identifier:
NCT01112163
First received: April 26, 2010
Last updated: April 27, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention
Ischemic Heart Disease
 Device: Enhanced external counter pulsation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Enhanced External Counter Pulsation on Left Ventricular Systolic and Diastolic Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Herning Hospital:

Primary Outcome Measures:
  • Left ventricular longitudinal strain [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    A measure of left ventricular shortening during systole assessed by speckle tracking with trans thoracic echocardiography


Secondary Outcome Measures:
  • Pulse wave velocity [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    Pulse wave velocity is a measure of aortic arterial stiffness. The outcome is the relationhip between pulse wave velocity and d/s ratio

  • left ventricular diastolic function [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    EECP reduces left ventricular after load and increases cardiac output. Left ventricular diastolic function is assessed by tissue Doppler imaging


Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112163

Locations
Denmark
Regionshospitalet Herning
Herning, Denmark, 7400
Sponsors and Collaborators
Herning Hospital
Investigators
Principal Investigator: Ashkan Eftekhari, MD PhD Regionshospitalet Herning / Dept. Pharmacology Aarhus University
Study Chair: Ole May, MD PhD Regionshospitalet Herning
  More Information

No publications provided

Responsible Party: Medicinsk Afdeling Regionshospitalet Herning, Hospitalenheden Vest
ClinicalTrials.gov Identifier: NCT01112163     History of Changes
Other Study ID Numbers: EECP-VV
Study First Received: April 26, 2010
Last Updated: April 27, 2010
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Herning Hospital:
ischemic heart disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Coronary Disease
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013