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Transmyocardial Laser Revascularization and Cardiovascular Magnetic Resonance Imaging (Amsterdam)

This study has been terminated.
(Lack of patient population)
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Information provided by (Responsible Party):
Piedmont Healthcare Identifier:
First received: January 31, 2011
Last updated: September 4, 2013
Last verified: August 2013
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: None (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:

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 ]

Enrollment: 2
Study Start Date: January 2011
Study Completion Date: August 2013
Primary Completion Date: August 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01287910

United States, Georgia
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Sponsors and Collaborators
Piedmont Healthcare
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Principal Investigator: Morris Brown, MD Piedmont Heart Institute
  More Information

Responsible Party: Piedmont Healthcare Identifier: NCT01287910     History of Changes
Other Study ID Numbers: Amsterdam
Study First Received: January 31, 2011
Last Updated: September 4, 2013

Keywords provided by Piedmont Healthcare:
Chest pain

Additional relevant MeSH terms:
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on September 21, 2017