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Clinical Trial: Cardio Vascu-Grow for treatment of coronary heart disease
This study is currently recruiting patients.
Purpose
Treatment for no-options heart patients with coronary artery disease. Procedure involves the injection into the heart of a protein growth factor that stimulates the growth of new blood vessels around blocked coronary arteries.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Coronary Disease Coronary Heart Disease Myocardial Ischemia Coronary Arteriosclerosis | Drug: Human Fibroblast Growth Factor 1 | Phase I Phase II |
MedlinePlus related topics: Coronary Disease; Heart Diseases; Heart Diseases--Prevention; Vascular Diseases
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Expected Total Enrollment: 32
Study start: December 2002
Patients with chronic, stable angina with documented coronary artery disease are eligible for the study.
Eligibility
Ages Eligible for Study: 25 Years - 90 Years, Genders Eligible for Study: Both
Criteria
3 month history of chronic, stable angina.
Mini-thoracotomy and anesthesia not contraindicated.
Not eligible for by-pass or PTCA procedures.
One/two/three vessel disease with documentation of greater than 70% narrowing of a major coronary artery, or diffuse coronary artery disease.
Heart ejection fraction >25%.
Normal retinal eye exam.
Subjects must be on conventional medication including one of the following: beta-blockers, calcium entry blockers, long-acting nitrates.
Female subjects must be post-menopausal or sterilized, or if of child-bearing age, not breast-feeding, on contraceptive drugs or devices, and have no intention of becoming pregnant during the course of the study.
Location and Contact Information
Maryland
St. Joseph Medical Center, Towson, Maryland, 21204, United States; Recruiting
Mary Riggs, R.N. 301-208-9100 Maryr@C2R.net
John C Laschinger, M.D., Principal Investigator
Pennsylvania
Penn State Milton Hershey Medical Center, Hershey, Pennsylvania, 17033, United States; Recruiting
John Boehmer, M.D., Principal Investigator
More Information
web site of sponsor
Record last reviewed: December 2002
Last Updated: October 13, 2004
Record first received: March 14, 2002
ClinicalTrials.gov Identifier: NCT00032318
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
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