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

Tracking Information
First Submitted Date ICMJE	April 26, 2010
First Posted Date ICMJE	April 28, 2010
Last Update Posted Date	April 28, 2010
Study Start Date ICMJE	March 2010
Estimated Primary Completion Date	November 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 27, 2010)	Left ventricular longitudinal strain [ Time Frame: 60 minutes ]; A measure of left ventricular shortening during systole assessed by speckle tracking with trans thoracic echocardiography
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: April 27, 2010)	Pulse wave velocity [ Time Frame: 60 minutes ]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 ]EECP reduces left ventricular after load and increases cardiac output. Left ventricular diastolic function is assessed by tissue Doppler imaging
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	The Effect of Enhanced External Counter Pulsation on Left Ventricular Systolic and Diastolic Function
Official Title ICMJE	The Effect of Enhanced External Counter Pulsation on Left Ventricular Systolic and Diastolic Function
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Ischemic Heart Disease
Intervention ICMJE	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.
Study Arms	Experimental: Enhanced external counter pulsation; One session of enhanced external counter pulsation (60 minutes); Intervention: Device: Enhanced external counter pulsation
Publications *	May O, Søgaard 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). doi: 10.4088/PCC.14m01748. eCollection 2015.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: April 27, 2010)	20
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	November 2010
Estimated Primary Completion Date	November 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Denmark
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01112163
Other Study ID Numbers ICMJE	EECP-VV
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Medicinsk Afdeling Regionshospitalet Herning, Hospitalenheden Vest
Study Sponsor ICMJE	Herning Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Ashkan Eftekhari, MD PhD Regionshospitalet Herning / Dept. Pharmacology Aarhus University Study Chair: Ole May, MD PhD Herning Hospital
PRS Account	Herning Hospital
Verification Date	March 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP