Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

TDI Preejection Velocities and Myocardial Viability

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Charles University, Czech Republic.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Ministry of Health, Czech Republic
Czech Ministry of Education
Information provided by:
Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT00231205
First received: September 30, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 30, 2005
September 30, 2005
January 2005
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
TDI Preejection Velocities and Myocardial Viability
TDI-Derived Myocardial Preejection Velocities in Patients With Chronic Ischemic Left Ventricular Dysfunction Undergoing Surgical Revascularization

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Longitudinal
Not Provided
Not Provided
Not Provided
Not Provided
Coronary Artery Disease
Procedure: Revascularization
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2009
Not Provided

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.

Both
18 Years and older
No
Contact: Martin Penicka, MD, PhD +420 26716 2724 penicka@fnkv.cz
Contact: Petr Tousek, MD +420 26716 2724 tousek@email.cz
Czech Republic
 
NCT00231205
IGA 8524-5
Not Provided
Not Provided
Charles University, Czech Republic
  • Ministry of Health, Czech Republic
  • Czech Ministry of Education
Principal Investigator: Martin Penicka, MD, PhD Charles University, Prague, Czech Republic
Charles University, Czech Republic
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP