A Study of Anginera In Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00364390
Recruitment Status : Unknown
Verified March 2009 by Theregen, Inc..
Recruitment status was:  Active, not recruiting
First Posted : August 15, 2006
Last Update Posted : March 30, 2009
Information provided by:
Theregen, Inc.

Brief Summary:
This is a first in man, Phase I safety study of Anginera in adults with Left Ventricular Dysfunction (LVD) and Reversible Myocardial Ischemia undergoing a CABG procedure.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Anginera, a human tissue replacement therapy Phase 1

Detailed Description:

A prospective, multicenter, open-label Phase I safety study of Anginera. Adults with Left Ventricular Dysfunction and reversible myocardial ischemia who are undergoing a CABG procedure, who have at least one graftable vessel and at least one coronary vessel not amenable to bypass or PCI (Percutaneous Coronary Intervention)will be recruited. Three pieces of Anginera will be placed on the area of the surface of the ventricle, including the area supplied by the vessel or vessels that cannot be bypassed, as well as surrounding myocardium. Patients will be followed for 12 months after the surgery at which Anginera is implanted.

The primary objective is to determine safety. The secondary objectives are to determine regional myocardial perfusion and regional left ventricular performance and to investigate the utility of measures of patient perception of improvement.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Open Label Pilot Study to Evaluate the Safety, Efficacy and Tolerability of Anginera for Adults With Left Ventricular Dysfunction AND Reversible Myocardial Ischemia Undergoing CABG Surgery
Study Start Date : April 2006
Actual Primary Completion Date : November 2008
Estimated Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Physical exam and interval medical history
  2. CBC and differential
  3. Serum cardiac markers—Troponin I
  4. Serum chemistries and urinalysis
  5. Resting electrocardiogram (ECG)
  6. 24 hour Holter monitor
  7. Adverse Events reporting

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients have been referred for CABG
  • Left ventricular ejection fraction (LVEF) greater than 20%
  • Patients have CAD involving at least two (2) coronary arteries, with at least one or more vessel(s) having disease not amenable to bypass grafting or PCI
  • There is a region of myocardium served by the vessel(s) defined above that has objective evidence of multi-distribution reversible ischemia based on a 17-segment assessment of reversible defects on SPECT/Thallium.

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from the study:

  1. Patient undergoing valve replacement or valve modification
  2. Patient with significant or malignant ventricular arrhythmias, defined as a patient being treated for ventricular tachycardia and/or ventricular fibrillation with an implantable cardioverter/defibrillator (ICD) or a patient being treated with Amiodarone for these same tachyarrhythmias. (Note: having an implantable cardioverter/defibrillator (ICD) per se, in a patient who does not have significant or malignant ventricular arrhythmias, does not exclude the patient from this study.)
  3. Patient requires urgent coronary artery bypass surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00364390

United States, Connecticut
Yale University School of Medicine,
New Haven, Connecticut, United States, 06519
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Theregen, Inc.
Principal Investigator: Bartley P Griffith, MD University of Maryland
Principal Investigator: George Tellides, M.D., Ph.D. Yale University

Additional Information:
Responsible Party: Gary Gentzkow, M.D. Chief Medical Officer, Theregen, Inc. Identifier: NCT00364390     History of Changes
Other Study ID Numbers: ITT-101
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: March 30, 2009
Last Verified: March 2009

Keywords provided by Theregen, Inc.:

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases