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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Device: Enhanced external counter pulsation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced external counter pulsation<br>One session of enhanced external counter pulsation (60 minutes) | Device: Enhanced external counter pulsation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular longitudinal strain | 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 | 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 | EECP reduces left ventricular after load and increases cardiac output. Left ventricular diastolic function is assessed by tissue Doppler imaging | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic heart disease