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

Ischemic Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01112163
• Other study ID #: EECP-VV
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 26, 2010
• Last updated: April 27, 2010
• Start date: March 2010
• Est. completion date: November 2010

Study information

• Verified date: March 2010
• Source: Herning Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Denmark	Regionshospitalet Herning	Herning

Sponsors (1)

Lead Sponsor	Collaborator
Herning Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular longitudinal strain	A measure of left ventricular shortening during systole assessed by speckle tracking with trans thoracic echocardiography	60 minutes	No
Secondary	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	No
Secondary	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	No