Transmyocardial Laser Revascularization and Cardiovascular Magnetic Resonance Imaging

Stopped early · Not applicable

Conditions studied: Angina, Chest Pain

In brief

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.

Key facts

Study ID

NCT01287910

Run by

Piedmont Healthcare

People needed

2

Starts

2011-01-01

Expected to finish

2013-08-01

Last updated by the study team

2013-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Piedmont Heart Institute — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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