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

H

Herning Hospital

Status

Unknown

Conditions

Ischemic Heart Disease

Treatments

Device: Enhanced external counter pulsation

Study type

Interventional

Funder types

Other

Identifiers

NCT01112163
EECP-VV

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Enhanced external counter pulsation
Experimental group
Description:
One session of enhanced external counter pulsation (60 minutes)
Treatment:
Device: Enhanced external counter pulsation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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