Transmyocardial Laser Revascularization and Cardiovascular Magnetic Resonance Imaging

NCT01287910 | Terminated

• 1 other identifier: Amsterdam
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Angina; Chest Pain

Keywords

Cardiac; Angina; Chest pain

Outcome Measures

Primary Outcomes (1)

• Number of coronary arteries with blood flow defects evaluated by magnetic resonance imaging (MRI) or computed tomography (CT)

  6 months

Study Arms (1)

All Patients

OTHER

All patients undergo the same study procedures

Other: Cardiac MRI

Interventions

Cardiac MRI OTHER

Cardiac MRI within 30 days prior to TMR procedure and 6 months after TMR procedure.

All Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Piedmont Healthcare: lead
• Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.: collaborator

Study Sites (1)

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Angina Pectoris; Chest Pain

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Morris Brown, MD

  Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: February 2, 2011
• Study Start: January 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 5, 2013

Record last verified: 2013-08

Locations

US (1)