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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01112163
Enrollment
20
Registered
2010-04-28
Start date
2010-03-31
Completion date
2010-11-30
Last updated
2010-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Heart Disease

Keywords

ischemic heart disease

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.

Interventions

DEVICEEnhanced 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.

Sponsors

Herning Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Left ventricular longitudinal strain60 minutesA measure of left ventricular shortening during systole assessed by speckle tracking with trans thoracic echocardiography

Secondary

MeasureTime frameDescription
Pulse wave velocity60 minutesPulse 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 function60 minutesEECP reduces left ventricular after load and increases cardiac output. Left ventricular diastolic function is assessed by tissue Doppler imaging

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026