Clinical trial NCT01112163: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Heart Disease
Keywords: ischemic heart disease
Lead sponsor: Herning Hospital
Sponsor class: OTHER
First posted: 2010-04-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Left ventricular longitudinal strain
timeFrame: 60 minutes
Secondary outcomes:
measure: Pulse wave velocity
timeFrame: 60 minutes
measure: left ventricular diastolic function
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Regionshospitalet Herning
Study officials:
affiliation: Regionshospitalet Herning / Dept. Pharmacology Aarhus University
name: Ashkan Eftekhari, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Herning Hospital
name: Ole May, MD PhD
role: STUDY_CHAIR
References:
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.