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TDI Preejection Velocities and Myocardial Viability

NCT ID: NCT00231205

Last Updated: 2005-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Keywords

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viability myocardium preejection velocity CAD echocardiography tissue Doppler

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Revascularization

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Czech Republic

OTHER_GOV

Sponsor Role collaborator

Czech Ministry of Education

OTHER_GOV

Sponsor Role collaborator

Charles University, Czech Republic

OTHER

Sponsor Role lead

Principal Investigators

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Martin Penicka, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Charles University, Prague, Czech Republic

Locations

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III. Internal-cardiological clinic, 3rd Medical Faculty, Charles University

Prague, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Martin Penicka, MD, PhD

Role: CONTACT

Phone: +420 26716 2724

Email: [email protected]

Petr Tousek, MD

Role: CONTACT

Phone: +420 26716 2724

Email: [email protected]

Facility Contacts

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Martin Penicka, MD, PhD

Role: primary

Petr Tousek, MD

Role: backup

Other Identifiers

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IGA 8524-5

Identifier Type: -

Identifier Source: org_study_id