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

NCT01112163 | Unknown

• 1 other identifier: EECP-VV
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease

Keywords

ischemic heart disease

Outcome Measures

Primary Outcomes (1)

• Left ventricular longitudinal strain

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

  60 minutes

Secondary Outcomes (2)

• Pulse wave velocity

  60 minutes

• left ventricular diastolic function

  60 minutes

Study Arms (1)

Enhanced external counter pulsation

EXPERIMENTAL

One session of enhanced external counter pulsation (60 minutes)

Device: Enhanced external counter pulsation

Interventions

Enhanced external counter pulsation DEVICE

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.

Enhanced external counter pulsation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Angina pectoris, CCS-class 2-4
• Reversal ischemia
• Pathological coronary angiogram without the possibility of revascularization
• Sinus rhythm

You may not qualify if:

• 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

Sponsors & Collaborators

• Herning Hospital: lead

Study Sites (1)

Regionshospitalet Herning

Herning, 7400, Denmark

Location

Related Publications (1)

• 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.

  PMID: 26693035 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Ashkan Eftekhari, MD PhD

  Regionshospitalet Herning / Dept. Pharmacology Aarhus University

  PRINCIPAL INVESTIGATOR

• Ole May, MD PhD

  Herning Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: April 28, 2010
• Study Start: March 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: April 28, 2010

Record last verified: 2010-03

Locations

DK (1)