TDI Preejection Velocities and Myocardial Viability
Recruitment status was Recruiting
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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 Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective |
| Official Title: | TDI-Derived Myocardial Preejection Velocities in Patients With Chronic Ischemic Left Ventricular Dysfunction Undergoing Surgical Revascularization |
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | December 2009 |
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 |
Inclusion Criteria:
- occluded or suboccluded left anterior descending coronary artery (LAD) at recent coronary angiography (< 3 months);
- LV ejection fraction < 40%;
- 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| Contact: Martin Penicka, MD, PhD | +420 26716 2724 | penicka@fnkv.cz |
| Contact: Petr Tousek, MD | +420 26716 2724 | tousek@email.cz |
| 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 | |
| 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 May 23, 2013