Transmyocardial Laser Revascularization and Cardiovascular Magnetic Resonance Imaging

Not Applicable

Terminated

• Conditions: Chest Pain; Angina
• Interventions: Other: Cardiac MRI

• Registration Number: NCT01287910
• Lead Sponsor: Piedmont Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-31
• Study First Submitted QC: 2011-02-01
• Study First Posted: 2011-02-02
• Status Verified: 2013-08
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-09-04
• Last Update Posted: 2013-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Patients	Cardiac MRI	All patients undergo the same study procedures

Primary Outcome Measures

Name	Time	Method
Number of coronary arteries with blood flow defects evaluated by magnetic resonance imaging (MRI) or computed tomography (CT)	6 months

Trial Locations

Locations (1)

Piedmont Heart Institute; 🇺🇸 Atlanta, Georgia, United States