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Fibroblast Growth Factor-1 (FGF-1) for the Treatment of Coronary Heart Disease (ACORD)
This study is currently recruiting participants.
Verified by CardioVascular BioTherapeutics, Inc., November 2008
Sponsored by: CardioVascular BioTherapeutics, Inc.
Information provided by: CardioVascular BioTherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00117936
  Purpose

Treatment for no-option heart patients with coronary artery disease. Procedure includes the injection into the heart of a protein growth factor, administered by the Cordis Corp. MyoStar injection catheter, to stimulate the growth of blood vessels around blocked coronary arteries.


Condition Intervention Phase
Coronary Disease
Coronary Heart Disease
Myocardial Ischemia
Coronary Arteriosclerosis
Drug: Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
Drug: Human Recombinant Fibroblast Growth Factor-1 (FGF1-141)
Phase II

MedlinePlus related topics: Coronary Artery Disease Heart Diseases
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Human Recombinant Fibroblast Growth Factor-1 (FGF-1) for Intramyocardial Injection for the Treatment of Coronary Heart Disease

Further study details as provided by CardioVascular BioTherapeutics, Inc.:

Primary Outcome Measures:
  • Change in cardiac perfusion as measured by SPECT scan under stress conditions and change in vascular bed density at the sites of injections as determined by angiography [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exercise treadmill test: time (or change in time) to onset of at least 1 mm additional horizontal or downsloping ST-segment depression, or time to ETT in the absence of at least 1 mm additional ST-segment depression due to pain (angina) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
Drug: Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
One time injection of 2 ug/kg of FGF 1-141, via a catheter
2: Experimental
Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
Drug: Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
One time injection of 20 ug/kg FGF 1-141 via a catheter
3: Experimental
Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
Drug: Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
One time injection of 40 ug/kg FGF 1-141, via a catheter
4: Placebo Comparator
Human Recombinant Fibroblast Growth Factor-1 (FGF 1-141)
Drug: Human Recombinant Fibroblast Growth Factor-1 (FGF1-141)
One time injection of 0 ug/kg (placebo group), via a catheter

Detailed Description:

Patients with chronic, stable angina with documented coronary artery disease are eligible for the study.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must sign an informed consent form.
  2. Age ≥ 25 and ≤ 75 years and may be of either gender and any race.
  3. At least a 3 month history of chronic, stable angina that is documented as triggered by physical effort, and is relieved by rest and/or nitroglycerin.
  4. Documented symptomatic CCS Anginal Classification of III to IV despite use of optimal medical therapy as noted in inclusion criterion 11.
  5. Pattern of CHD (coronary pathology) where percutaneous interventional therapy and/or CABG is not recommended by the treating cardiologist.
  6. One/two/three vessel disease as evidenced either by an angiographic documentation of advanced atherosclerotic narrowing of a major epicardial coronary artery, or of diffuse type of CHD as evidenced by the appearance on coronary angiography of multiple stenoses, multiple atherosclerotic plaques, and/or peripheral occlusion(s) of coronary vessel(s) with and without a history of MIs.
  7. Subjects are required to demonstrate a radionuclide or angiographically determined left ventricular ejection fraction (LVEF) ≥ 40%.
  8. Pre-operative proof of reversible ischemia.
  9. No evidence of proliferative retinopathy or significant non-proliferative retinopathy.
  10. Subjects must be on optimal medical therapy for at least 2 months prior to entering the study, as documented by a medical history. This will include medical management, and subjects must enter the study on at least one of the following medications: beta-blockers, calcium entry blockers, ranolazine, or long-acting nitrates.
  11. Exercise duration during the qualifying treadmill tests at Visit 1 and Visit 2 is ≥ 3 and ≤ 9 minutes on a modified Bruce protocol.
  12. Exercise durations for the 2 qualifying treadmill tests at Visits 1 and 2 do not differ by more than 20% of the longer of the 2 times and do not differ by more than 60 seconds.
  13. The primary reason for stopping the 2 qualifying treadmill tests at Visits 1 and 2 must be angina and/or a horizontal or down sloping ST-segment depression of ≥ 1 mm during exercise, compared to pre-exercise ST segment, when measured 80 ms from the J point.
  14. A forced vital capacity (FVC) of ≥ 30% .
  15. A negative pregnancy test in women of childbearing potential within 7 days of the catheterization procedure.
  16. Female subjects must be post-menopausal or sterilized, or if she is of childbearing potential, she is not breast feeding and she has no intention to become pregnant during the course of the study, and she is using contraceptive drugs or devices.
  17. Ability to complete the study in compliance with the protocol.

Exclusion Criteria

  1. History of undergoing a CABG, PTCA or TMR or evidence of an acute MI in the last 3 months.
  2. Subjects with malignancies or a history of malignancies (with the exception of basal cell carcinoma [BCC] of the skin) will be excluded from the study. Those subjects with a history of BCC are eligible for enrollment, and will be monitored by a qualified dermatologist every 8 weeks for a period of 6 months for evaluation of their skin condition. Subjects with existing BCC will be excluded from the study.
  3. Evidence of concurrent clinically significant infection (e.g., elevated white blood cell [WBC] count > 13,000 x 109/L, temperature > 38.5°C), evidence of "common cold" or "flu".
  4. Concomitant other structural heart disease, such as heart valve disease, congenital heart disease, etc. other than evidence of congestive heart failure that is directly related to past ischemic events.
  5. Left ventricular thrombus (mobile or mural-based) as evidenced by ventriculogram or echocardiography.
  6. Creatine kinase (CK) levels >3 x upper limit of normal (ULN).
  7. Renal insufficiency requiring dialysis or laboratory evidence of a serum creatinine > 2.0 mg/dL.
  8. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x ULN.
  9. History of coagulation disorders or abnormal prothrombin time (PT) or partial thromboplastin time (PTT) > 1.5 x ULN, thrombocytopenia (< 100,000/µl), or ongoing anticoagulant therapy (with the exception of aspirin, up to 80 mg/day).
  10. History of blood cell diseases.
  11. Poorly controlled insulin-dependent diabetes mellitus (HbA1c > 8%)
  12. Pre-existing retinal disease, including proliferative retinopathy, severe nonproliferative retinopathy.
  13. Use of any illicit recreational drugs within the past year.
  14. A positive test result for human immunodeficiency virus (HIV) antibody.
  15. Screening ECG results demonstrating recent evidence of transmural ischemia.
  16. Clinically significant ECG abnormalities that interfere with ST-T wave analysis, e.g.:

    • QRS duration > 0.12 seconds.
    • QTc > 450 ms in males or > 460 ms in females.
    • High-grade atrioventricular (AV) block.
    • Left bundle branch block (LBBB).
    • Left ventricular hypertrophy (LVH) with secondary ST-T changes.
    • Frequent, recurrent, or sustained ventricular arrhythmia.
    • Resting ST segment depression > 1 mm (measured 80 ms beyond the J point) at baseline.
  17. Subjects having a concomitant life-threatening disease in which their life expectancy is estimated to be less than 2 years.
  18. Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent and comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the trial.
  19. Use of an investigational drug, device or product, or participation in a drug research study within a period of 30 days prior to receiving IMP.
  20. Any subject with unstable angina.
  21. Heart failure New York Heart Association (NYHA) Functional Class III or IV.
  22. Uncontrolled hypertension precluding exercise testing and/or contributing to anginal severity (systolic blood pressure [SBP] > 200 mmHg or diastolic blood pressure [DBP] > 110 mmHg), or significant hypotension (SBP < 90 mmHg or DBP < 60 mmHg).
  23. Subjects currently on External Counter Pulsation therapy or who have received this therapy within 3 months prior to the screening date.
  24. Any mobility or pulmonary complication that impedes the subject's ability to perform an exercise stress test.
  25. Total fasting serum cholesterol ≥ 200 mg/dL (if levels higher than 200 mg/dL, additional medical interventions can be initiated to bring levels below 200 mg/dL).
  26. History of heparin-induced thrombocytopenia.
  27. Subjects with a history of recurrent symptomatic atrial fibrillation.
  28. Aortic valve replacement.
  29. Medical history and physical examination displaying any evidence that catheterization is contraindicated.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117936

Contacts
Contact: Allison Caplan 702-839-7235 acaplan@cvbt.com

Locations
United States, Alabama
Princeton Baptist Medical Center Recruiting
Birmingham, Alabama, United States
Contact: Susan DeRamus     205-780-4330     sderamus@cardiologypc.com    
Principal Investigator: Farrell Mendelsohn, MD            
United States, Florida
Florida Hospital and Cardiovascular Institute Recruiting
Orlando, Florida, United States
Contact: Leann Goodwin     407-303-7556     leann.goodwin@flhosp.org    
Principal Investigator: Andrew Taussig, MD            
United States, Minnesota
Minneapolis Heart Institute Foundation Recruiting
Minneapolis, Minnesota, United States
Contact: Patricia Mitchell     612-863-6287     patricia.mitchell@allina.com    
Principal Investigator: Timothy Henry, MD            
United States, Ohio
Fairfield Cardiac Cath Lab Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Mary Lou Sauer, RN     513-603-8236        
Principal Investigator: Charlie Hattemer, MD            
Sponsors and Collaborators
CardioVascular BioTherapeutics, Inc.
Investigators
Principal Investigator: Nabil Dib, MD Mercy Gilbert Medical Center, Gilbert, AZ
  More Information

web site of sponsor  This link exits the ClinicalTrials.gov site

Responsible Party: CardioVascular BioTherapeutics ( Dr. John Jacobs, VP and COO )
Study ID Numbers: CVBT-CHD07-01
Study First Received: June 30, 2005
Last Updated: December 10, 2008
ClinicalTrials.gov Identifier: NCT00117936  
Health Authority: United States: Food and Drug Administration

Keywords provided by CardioVascular BioTherapeutics, Inc.:
Angiogenesis
No-option heart patients
Blocked coronary artery
Revascularization
FGF-1
growth factor

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Arteriosclerosis
Coronary Artery Disease

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009