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

NCT ID: NCT01112163

Last Updated: 2010-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-11-30

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.

Detailed Description

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Conditions

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Ischemic Heart Disease

Keywords

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ischemic heart disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Enhanced external counter pulsation

One session of enhanced external counter pulsation (60 minutes)

Group Type EXPERIMENTAL

Enhanced external counter pulsation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herning Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hospitalenheden Vest

Principal Investigators

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Ashkan Eftekhari, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Regionshospitalet Herning / Dept. Pharmacology Aarhus University

Ole May, MD PhD

Role: STUDY_CHAIR

Herning Hospital

Locations

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Regionshospitalet Herning

Herning, , Denmark

Site Status

Countries

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Denmark

References

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May O, Sogaard HJ. Enhanced External Counterpulsation Is an Effective Treatment for Depression in Patients With Refractory Angina Pectoris. Prim Care Companion CNS Disord. 2015 Aug 20;17(4):10.4088/PCC.14m01748. doi: 10.4088/PCC.14m01748. eCollection 2015.

Reference Type DERIVED
PMID: 26693035 (View on PubMed)

Other Identifiers

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EECP-VV

Identifier Type: -

Identifier Source: org_study_id