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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01112163
Recruitment Status : Unknown
Verified March 2010 by Herning Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : April 28, 2010
Last Update Posted : April 28, 2010
Information provided by:
Herning Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Ischemic Heart Disease Device: Enhanced external counter pulsation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Enhanced External Counter Pulsation on Left Ventricular Systolic and Diastolic Function
Study Start Date : March 2010
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Left ventricular longitudinal strain [ Time Frame: 60 minutes ]
    A measure of left ventricular shortening during systole assessed by speckle tracking with trans thoracic echocardiography

Secondary Outcome Measures :
  1. 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

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01112163

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Regionshospitalet Herning
Herning, Denmark, 7400
Sponsors and Collaborators
Herning Hospital
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Principal Investigator: Ashkan Eftekhari, MD PhD Regionshospitalet Herning / Dept. Pharmacology Aarhus University
Study Chair: Ole May, MD PhD Herning Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Medicinsk Afdeling Regionshospitalet Herning, Hospitalenheden Vest Identifier: NCT01112163    
Other Study ID Numbers: EECP-VV
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: April 28, 2010
Last Verified: March 2010
Keywords provided by Herning Hospital:
ischemic heart disease
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases