Transmyocardial Laser Revascularization and Cardiovascular Magnetic Resonance Imaging (Amsterdam)

Piedmont Healthcare

Status: Terminated

Conditions: Chest Pain; Angina

Treatments: Other: Cardiac MRI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01287910

Amsterdam

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2 participants in 1 patient group

All Patients

Other group

Description:

All patients undergo the same study procedures

Treatment:

Other: Cardiac MRI