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Transmyocardial Laser Revascularization and Cardiovascular Magnetic Resonance Imaging (Amsterdam)

This study is currently recruiting participants.
Verified December 2012 by Piedmont Healthcare
Sponsor:
Collaborator:
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Information provided by (Responsible Party):
Piedmont Healthcare
ClinicalTrials.gov Identifier:
NCT01287910
First received: January 31, 2011
Last updated: December 16, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Angina
Chest Pain
 Other: Cardiac MRI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Effect of Transmyocardial Laser Revascularization on Myocardial Perfusion and Left Ventricular Structure by Cardiovascular Magnetic Resonance Imaging and Dynamic Volumetric Computed Tomography

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Piedmont Healthcare:

Primary Outcome Measures:
  • Number of coronary arteries with blood flow defects evaluated by magnetic resonance imaging (MRI) or computed tomography (CT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 13
Study Start Date: January 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
All Patients
All patients undergo the same study procedures
 Other: Cardiac MRI
Cardiac MRI within 30 days prior to TMR procedure and 6 months after TMR procedure.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287910

Contacts
Contact: Jennifer Jacobs 404-605-3118 jennifer.jacobs@piedmont.org
Contact: Morris Brown, MD 404-605-5699 morris.brown@piedmont.org

Locations
United States, Georgia
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States, 30309
Contact: Jennifer Jacobs     404-605-3118     jennifer.jacobs@piedmont.org    
Contact: Morris Brown, MD     404-605-5699     morris.brown@piedmont.org    
Sponsors and Collaborators
Piedmont Healthcare
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Investigators
Principal Investigator: Morris Brown, MD Piedmont Heart Institute
  More Information

No publications provided

Responsible Party: Piedmont Healthcare
ClinicalTrials.gov Identifier: NCT01287910     History of Changes
Other Study ID Numbers: Amsterdam
Study First Received: January 31, 2011
Last Updated: December 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Piedmont Healthcare:
Cardiac
Angina
Chest pain

Additional relevant MeSH terms:
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013