Transmyocardial Laser Revascularization and Cardiovascular Magnetic Resonance Imaging

Chest Pain Clinical Trial

— Amsterdam  

Official title:

Effect of Transmyocardial Laser Revascularization on Myocardial Perfusion and Left Ventricular Structure by Cardiovascular Magnetic Resonance Imaging and Dynamic Volumetric Computed Tomography

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01287910
• Other study ID #: Amsterdam
• Status: Terminated
• Phase: N/A
• First received: January 31, 2011
• Last updated: September 4, 2013
• Start date: January 2011
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Piedmont Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Angina
• Chest Pain

Intervention

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

Locations

Country	Name	City	State
United States	Piedmont Heart Institute	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Piedmont Healthcare	Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of coronary arteries with blood flow defects evaluated by magnetic resonance imaging (MRI) or computed tomography (CT)		6 months	No