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

Not Applicable

• Conditions: Ischemic Heart Disease
• Interventions: Device: Enhanced external counter pulsation

• Registration Number: NCT01112163
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-03
• Study Start: 2010-03
• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2010-04-27
• Last Update Submitted: 2010-04-27
• Study First Posted: 2010-04-28
• Last Update Posted: 2010-04-28
• Primary Completion: 2010-11
• Study Completion: 2010-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enhanced external counter pulsation	Enhanced external counter pulsation	One session of enhanced external counter pulsation (60 minutes)

Primary Outcome Measures

Name	Time	Method
Left ventricular longitudinal strain	60 minutes	A measure of left ventricular shortening during systole assessed by speckle tracking with trans thoracic echocardiography

Secondary Outcome Measures

Name	Time	Method
Pulse wave velocity	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
left ventricular diastolic function	60 minutes	EECP reduces left ventricular after load and increases cardiac output. Left ventricular diastolic function is assessed by tissue Doppler imaging

Trial Locations

Locations (1)

Regionshospitalet Herning; 🇩🇰 Herning, Denmark