TDI Preejection Velocities and Myocardial Viability

September 30, 2005 updated by: Charles University, Czech Republic

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Martin Penicka, MD, PhD
  • Phone Number: +420 26716 2724
  • Email: penicka@fnkv.cz

Study Contact Backup

  • Name: Petr Tousek, MD
  • Phone Number: +420 26716 2724
  • Email: tousek@email.cz

Study Locations

  • Czech Republic
      • Prague, Czech Republic, 100 00
        • Recruiting
        • III. Internal-cardiological clinic, 3rd Medical Faculty, Charles University
        • Contact:
          • Martin Penicka, MD, PhD
          • Phone Number: +420 26716 2724
          • Email: penicka@fnkv.cz
        • Contact:
        • Principal Investigator:
          • Martin Penicka, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Collaborators

Ministry of Health, Czech Republic
Czech Ministry of Education

Investigators

  • Principal Investigator: Martin Penicka, MD, PhD, Charles University, Prague, Czech Republic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion

December 1, 2009

Study Registration Dates

First Submitted

September 30, 2005

First Submitted That Met QC Criteria

September 30, 2005

First Posted (Estimate)

October 4, 2005

Study Record Updates

Last Update Posted (Estimate)

October 4, 2005

Last Update Submitted That Met QC Criteria

September 30, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGA 8524-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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