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
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Procedure: Revascularization

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Longitudinal
Official Title: TDI-Derived Myocardial Preejection Velocities in Patients With Chronic Ischemic Left Ventricular Dysfunction Undergoing Surgical Revascularization

Resource links provided by NLM:


Further study details as provided by Charles University, Czech Republic:

Estimated Enrollment: 200
Study Start Date: January 2005
Estimated Study Completion Date: December 2009
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231205

Contacts
Contact: Martin Penicka, MD, PhD +420 26716 2724 penicka@fnkv.cz
Contact: Petr Tousek, MD +420 26716 2724 tousek@email.cz

Locations
Czech Republic
III. Internal-cardiological clinic, 3rd Medical Faculty, Charles University Recruiting
Prague, Czech Republic, 100 00
Contact: Martin Penicka, MD, PhD    +420 26716 2724    penicka@fnkv.cz   
Contact: Petr Tousek, MD    +420 26716 2724    tousek@email.cz   
Principal Investigator: Martin Penicka, MD, PhD         
Sponsors and Collaborators
Charles University, Czech Republic
Ministry of Health, Czech Republic
Czech Ministry of Education
Investigators
Principal Investigator: Martin Penicka, MD, PhD Charles University, Prague, Czech Republic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00231205     History of Changes
Other Study ID Numbers: IGA 8524-5
Study First Received: September 30, 2005
Last Updated: September 30, 2005
Health Authority: Czech Republic: Czech Ministry of Health.

Keywords provided by Charles University, Czech Republic:
viability
myocardium
preejection velocity
CAD
echocardiography
tissue Doppler

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014