- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01287910
Transmyocardial Laser Revascularization and Cardiovascular Magnetic Resonance Imaging (Amsterdam)
September 4, 2013 updated by: Piedmont Healthcare
Effect of Transmyocardial Laser Revascularization on Myocardial Perfusion and Left Ventricular Structure by Cardiovascular Magnetic Resonance Imaging and Dynamic Volumetric Computed Tomography
The primary goal of this study is to better understand how Transmyocardial Laser Revascularization (TMR) affects the functioning of the heart and, in turn, relieves angina in individuals with coronary heart disease using Magnetic Resonance (MR) images and Computed Tomography (CT) images in some patients.
Study Overview
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30309
- Piedmont Heart Institute
-
-
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:
- Male or female 18 years of age or over
- Patients with medically refractory, severe, class III or IV angina based on the Canadian Cardiovascular Society angina scale as determined by a physician
- Ejection fraction 25% or greater
- Patients with significant ischemia in the myocardium and who are NOT candidates for treatment by direct coronary revascularization methods (i.e., CABG or PCI)
- Ability and willingness to consent and Authorization for use of PHI
Exclusion Criteria:
- Patient cannot undergo a surgical procedure or general anesthesia
- Patient not eligible for CMR study
- Severe unstable angina
- Q-wave MI within 3 weeks prior to TMR
- NQWMI within 2 weeks prior to TMR
- Decompensated heart failure (class III/IV) at the time of procedure
- Known increased bleeding risk
- Implanted pacemaker or defibrillator
- Clinically unstable arrhythmia
- Not able or willing to adhere to the study tests and procedures
- Inability or unwillingness to consent and Authorization for use of PHI
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
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: All Patients
All patients undergo the same study procedures
|
Cardiac MRI within 30 days prior to TMR procedure and 6 months after TMR procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of coronary arteries with blood flow defects evaluated by magnetic resonance imaging (MRI) or computed tomography (CT)
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Morris Brown, MD, Piedmont Heart Institute
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, 2011
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
January 31, 2011
First Submitted That Met QC Criteria
February 1, 2011
First Posted (Estimate)
February 2, 2011
Study Record Updates
Last Update Posted (Estimate)
September 5, 2013
Last Update Submitted That Met QC Criteria
September 4, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Amsterdam
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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