TDI Preejection Velocities and Myocardial Viability

Coronary Artery Disease Clinical Trial

Official title:

TDI-Derived Myocardial Preejection Velocities in Patients With Chronic Ischemic Left Ventricular Dysfunction Undergoing Surgical Revascularization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00231205
• Other study ID #: IGA 8524-5
• Status: Recruiting
• Phase: N/A
• First received: September 30, 2005
• Last updated: September 30, 2005
• Start date: January 2005
• Est. completion date: December 2009

Study information

• Verified date: September 2005
• Source: Charles University, Czech Republic
• Contact: Martin Penicka, MD, PhD
• Phone: +420 26716 2724
• Email: penicka[@]fnkv.cz
• Is FDA regulated: No
• Health authority: Czech Republic: Czech Ministry of Health.
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to test accuracy of positive preejection velocity to predict left ventricular remodeling and long-term prognosis after revascularization in 200 patients with chronically dysfunctional myocardium. Patients will be followed for 3 years.

Our hypothesis is that tissue-Doppler-derived analysis of positive preejection velocity allows to select optimal responders to revascularization; it means individuals with the greatest benefit in terms of LV remodeling and long-term prognosis.

Description:

The objective of the project is to study clinical and prognostic value of new echocardiographic technique, so called positive preejection velocity (+VIC), in patients with chronic ischemic left ventricular (LV) dysfunction indicated for revascularization. Pilot studies has shown high accuracy of pulsed Tissue Doppler imaging (TDI)-derived resting pattern of +VIC to detect viable myocardium in patients with both acute myocardial infarction and chronically dysfunctional myocardium. The aim of the project is to test accuracy of +VIC to predict LV remodeling and long-term prognosis after revascularization in patients with chronically dysfunctional myocardium. Study population will consist of two groups of patients with stable ischemic LV dysfunction: group A- patients indicated for revascularization (n=200), group B- matched control group treated conservatively (case-control design) (n=100). All patients will be followed for 3 years. Endpoints include: 1) LV remodeling at 6 and 24 months and 2) MACE at 6, 12 and 36 months follow-up. Our hypothesis is that TDI-derived analysis of +VIC allows to select optimal responders to revascularization; it means individuals with the greatest benefit in terms of LV remodeling and long-term prognosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. occluded or suboccluded left anterior descending coronary artery (LAD) at recent coronary angiography (< 3 months);

2. LV ejection fraction < 40%;

3. 3 and more akinetic or severely hypokinetic segments in the LAD perfusion territory at resting echocardiography.

Exclusion Criteria:

• Patients with recent acute coronary syndrome, atrial fibrillation, bundle branch block, LV hypertrophy or aneurysm, significant valvular disease, pacemakers or internal defibrillators, poor echocardiographic image quality and contraindications for MRI are excluded.

Study Design

Observational Model: Case Control, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Revascularization

Locations

Country	Name	City	State
Czech Republic	III. Internal-cardiological clinic, 3rd Medical Faculty, Charles University	Prague

Sponsors (3)

Lead Sponsor	Collaborator
Charles University, Czech Republic	Czech Ministry of Education, Ministry of Health, Czech Republic

Country where clinical trial is conducted

Czech Republic,