Coronary Artery DiseaseNCT00661232
Multicenter Myocardial Viability Trial
An observational study of Coronary Artery Disease, run by CHI St. Luke's Health, Texas at 7 sites in 6 countries.
Trial summary
The purpose of this study is to test the hypothesis of whether contrast enhanced Magnetic Resonance Imaging can be used to predict improvement of the wall motion in regions of the heart with abnormal movement following bypass surgery or percutaneous angioplasty in various institutions across three continents. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 235 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 11 Aug 2003to 15 May 2011
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were recruited from 9 institutions on 3 different continent. All patients recruited for the study had a history of angiographically documented chronic coronary artery disease and resting wall motion abnormalities, and were scheduled for cardiac revascularization (coronary artery bypass surgery or percutaneous intervention).
Who may be able to join
- Age: > 21 years and < 85 years
- Sinus rhythm
- Weight < 120 kg
- LVEF > 30%
- Wall motion abnormality on Echo. or LV-gram
- Scheduled for revascularization - Angioplasty/Stent or CABG - within 30 days
Who cannot join
- Resting heart rate > 100 bpm
- Frequent atrial or ventricular ectopy
- Severe aortic stenosis or HOCM
- Unstable angina
- Myocardial infarction within 14 days
- Active congestive heart failure
Show all 9Show fewer
- Pregnancy
- Known allergy to gadolinium
- Contraindication to MRI
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
United States2 sites
St. Luke's Episcopal Hospital
Houston, Texas, 77030
St. Luke's Episcopal Location
Houston, Texas, 77030
About this study
Official title: An International, Multicenter Trial Assessing Myocardial Viability With Contrast - Enhanced Magnetic Resonance Imaging
The purpose of this study is to test the hypothesis of whether contrast enhanced Magnetic Resonance Imaging can be used to predict improvement of the wall motion in regions of the heart with abnormal movement following bypass surgery or percutaneous angioplasty in various institutions across three continents.
- Conditions
- Coronary Artery Disease
- Keywords
- Myocardial Viability, Delayed Enhancement Magnetic Resonance Imaging, Functional Recovery
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine whether the extent of irreversible myocardial injury as assessed by Delayed Enhancement Magnetic Resonance Imaging can predict the extent of functional recovery after revascularization in patients with chronic coronary artery disease (CAD).
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study start11 Aug 2003
- Primary completion14 Jan 2011
- Study completion15 May 2011
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHI St. Luke's Health, Texas
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Principal investigator, Scott D. Flamm, M.D., CHI St. Luke's Health, Texas
- Investigators
- Scott D Flamm, M.D., Principal investigator, CHI St. Luke's Health, Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661232
- Sponsor's protocol ID
- 1102-02-777
- Other IDs
- NDA# 20-937, IND# 66,506
- Status last verified
- Nov 2020
- First submitted
- 16 Apr 2008
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multicenter Trial Assessing Myocardial Viability With Contrast - Enhanced Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT00661232
- Acronym / sponsor ID
- 1102-02-777
- Conditions
- Coronary Artery Disease
- Keywords
- Myocardial Viability, Delayed Enhancement Magnetic Resonance Imaging, Functional Recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- CHI St. Luke's Health, TexasUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- 11 Aug 2003 (actual)
- Primary completion
- 14 Jan 2011 (actual)
- Study completion
- 15 May 2011 (actual)
- First posted
- 18 Apr 2008 (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 this study is to test the hypothesis of whether contrast enhanced Magnetic Resonance Imaging can be used to predict improvement of the wall motion in regions of the heart with abnormal movement following bypass surgery or percutaneous angioplasty in various institutions across three continents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were recruited from 9 institutions on 3 different continent. All patients recruited for the study had a history of angiographically documented chronic coronary artery disease and resting wall motion abnormalities, and were scheduled for cardiac revascularization (coronary artery bypass surgery or percutaneous intervention).
Key inclusion criteria (6 listed)
- Age: > 21 years and < 85 years
- Sinus rhythm
- Weight < 120 kg
- LVEF > 30%
- Wall motion abnormality on Echo. or LV-gram
Key exclusion criteria (9 listed)
- Resting heart rate > 100 bpm
- Frequent atrial or ventricular ectopy
- Severe aortic stenosis or HOCM
- Unstable angina
- Myocardial infarction within 14 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To examine whether the extent of irreversible myocardial injury as assessed by Delayed Enhancement Magnetic Resonance Imaging can predict the extent of functional recovery after revascularization in patients with chronic coronary artery disease (CAD).
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
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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.
Scott D Flamm, M.D. principal investigator
CHI St. Luke's Health, Texas
7 sites in 6 countries: 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 CHI St. Luke's Health, Texas at 7 sites in 6 countries.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Belgium, Denmark, Greece, Thailand and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine whether the extent of irreversible myocardial injury as assessed by Delayed Enhancement Magnetic Resonance Imaging can predict the extent of functional recovery after revascularization in patients with chronic coronary artery disease (CAD). (time frame: 36 months). It is what the study was designed to measure, not a finding.
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 2 Dec 2020.