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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Theregen, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Theregen, Inc.
ClinicalTrials.gov Identifier:
NCT00364390
First received: August 14, 2006
Last updated: March 27, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Coronary Artery Disease
Drug: Anginera, a human tissue replacement therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Theregen, Inc.:

Primary Outcome Measures:
  • Physical exam and interval medical history
  • CBC and differential
  • Serum cardiac markers—Troponin I
  • Serum chemistries and urinalysis
  • Resting electrocardiogram (ECG)
  • 24 hour Holter monitor
  • Adverse Events reporting

Estimated Enrollment: 12
Study Start Date: April 2006
Estimated Study Completion Date: February 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT00364390

Locations
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.
Investigators
Principal Investigator: Bartley P Griffith, MD University of Maryland
Principal Investigator: George Tellides, M.D., Ph.D. Yale University
  More Information

Additional Information:
No publications provided

Responsible Party: Gary Gentzkow, M.D. Chief Medical Officer, Theregen, Inc.
ClinicalTrials.gov Identifier: NCT00364390     History of Changes
Other Study ID Numbers: ITT-101
Study First Received: August 14, 2006
Last Updated: March 27, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Theregen, Inc.:
CABG
Anginera
CAD

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

ClinicalTrials.gov processed this record on September 30, 2014