Angina, Chest Pain
Conditions
Keywords
Cardiac, Angina, Chest pain
Brief summary
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.
Interventions
Cardiac MRI within 30 days prior to TMR procedure and 6 months after TMR procedure.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of coronary arteries with blood flow defects evaluated by magnetic resonance imaging (MRI) or computed tomography (CT) | 6 months |
Countries
United States