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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Herning Hospital
ClinicalTrials.gov Identifier:
NCT01112163
First received: April 26, 2010
Last updated: April 27, 2010
Last verified: March 2010

April 26, 2010
April 27, 2010
March 2010
November 2010   (final data collection date for primary outcome measure)
Left ventricular longitudinal strain [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
A measure of left ventricular shortening during systole assessed by speckle tracking with trans thoracic echocardiography
Same as current
Complete list of historical versions of study NCT01112163 on ClinicalTrials.gov Archive Site
  • Pulse wave velocity [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    EECP reduces left ventricular after load and increases cardiac output. Left ventricular diastolic function is assessed by tissue Doppler imaging
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ischemic Heart Disease
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.
Experimental: Enhanced external counter pulsation
One session of enhanced external counter pulsation (60 minutes)
Intervention: Device: Enhanced external counter pulsation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
20
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01112163
EECP-VV
No
Medicinsk Afdeling Regionshospitalet Herning, Hospitalenheden Vest
Herning Hospital
Not Provided
Principal Investigator: Ashkan Eftekhari, MD PhD Regionshospitalet Herning / Dept. Pharmacology Aarhus University
Study Chair: Ole May, MD PhD Regionshospitalet Herning
Herning Hospital
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP