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

Primary Purpose

Ischemic Heart Disease

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Enhanced external counter pulsation
Sponsored by
Herning Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring ischemic heart disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Regionshospitalet Herning

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Enhanced external counter pulsation

Arm Description

One session of enhanced external counter pulsation (60 minutes)

Outcomes

Primary Outcome Measures

Left ventricular longitudinal strain
A measure of left ventricular shortening during systole assessed by speckle tracking with trans thoracic echocardiography

Secondary Outcome Measures

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
left ventricular diastolic function
EECP reduces left ventricular after load and increases cardiac output. Left ventricular diastolic function is assessed by tissue Doppler imaging

Full Information

First Posted
April 26, 2010
Last Updated
April 27, 2010
Sponsor
Herning Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01112163
Brief Title
The Effect of Enhanced External Counter Pulsation on Left Ventricular Systolic and Diastolic Function
Official Title
The Effect of Enhanced External Counter Pulsation on Left Ventricular Systolic and Diastolic Function
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
November 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Herning Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
Keywords
ischemic heart disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced external counter pulsation
Arm Type
Experimental
Arm Description
One session of enhanced external counter pulsation (60 minutes)
Intervention Type
Device
Intervention Name(s)
Enhanced external counter pulsation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Left ventricular longitudinal strain
Description
A measure of left ventricular shortening during systole assessed by speckle tracking with trans thoracic echocardiography
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Pulse wave velocity
Description
Pulse wave velocity is a measure of aortic arterial stiffness. The outcome is the relationhip between pulse wave velocity and d/s ratio
Time Frame
60 minutes
Title
left ventricular diastolic function
Description
EECP reduces left ventricular after load and increases cardiac output. Left ventricular diastolic function is assessed by tissue Doppler imaging
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashkan Eftekhari, MD PhD
Organizational Affiliation
Regionshospitalet Herning / Dept. Pharmacology Aarhus University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ole May, MD PhD
Organizational Affiliation
Herning Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Regionshospitalet Herning
City
Herning
ZIP/Postal Code
7400
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26693035
Citation
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.
Results Reference
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The Effect of Enhanced External Counter Pulsation on Left Ventricular Systolic and Diastolic Function

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