Coronary Artery DiseaseNCT00231205
TDI Preejection Velocities and Myocardial Viability
An observational study of Coronary Artery Disease, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Revascularization
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2005to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
III. Internal-cardiological clinic, 3rd Medical Faculty, Charles University
Prague, 100 00
Martin Penicka, MD, PhD, +420 26716 2724, penicka@fnkv.cz
Petr Tousek, MD, +420 26716 2724, tousek@email.cz
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Revascularization
- Keywords
- viability, myocardium, preejection velocity, CAD, echocardiography, tissue Doppler
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevascularizationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startJan 2005
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Czech Republic, Czech Ministry of Education
- Investigators
- Martin Penicka, MD, PhD, Principal investigator, Charles University, Prague, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231205
- Sponsor's protocol ID
- IGA 8524-5
- Status last verified
- Sep 2005
- First submitted
- 30 Sep 2005
- Last updated
- 4 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TDI-Derived Myocardial Preejection Velocities in Patients With Chronic Ischemic Left Ventricular Dysfunction Undergoing Surgical Revascularization
- ClinicalTrials.gov ID
- NCT00231205
- Acronym / sponsor ID
- IGA 8524-5
- Conditions
- Coronary Artery Disease
- Keywords
- viability, myocardium, preejection velocity, CAD, echocardiography, tissue Doppler
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Ministry of Health, Czech Republic, Czech Ministry of Education
- Study start
- Jan 2005
- Study completion
- Dec 2009
- First posted
- 4 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revascularization | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Penicka, MD, PhD principal investigator
Charles University, Prague, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Penicka, MD, PhD (+420 26716 2724, penicka@fnkv.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2005.