Angiogenesis in Women With Angina Pectoris Who Are Not Candidates for Revascularization

NCT00438867 | Unknown Phase 3 DMC

• 1 other identifier: CT-3-001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 47

Brief Summary

The purpose of this study is to determine whether a one-time intracoronary infusion of Ad5FGF-4 is effective in reducing the time to onset myocardial ischemia as measured by exercise treadmill testing and improving myocardial blood flow as measured by SPECT imaging. Exercise capacity, angina functional class, patient symptoms and quality of life will also be evaluated to characterize the efficacy of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.

Conditions

Angina Pectoris

Keywords

angina; FGF-4; angiogenesis; growth factor; myocardia ischemia; revascularization

Outcome Measures

Primary Outcomes (1)

• Change in time to onset of ECG changes diagnostic of myocardial ischemia during ETT

  Month 6

Secondary Outcomes (10)

• Change in reversible perfusion defect size as measured by adenosine single-photon emission computed tomography with technetium-99m sestamibi (SPECT)(principal secondary endpoint)

  Month 6

• Change in total exercise treadmill time

  Months 3, 6 and 12

• Change in time to onset ECG changes diagnostic myocardial ischemia during ETT

  Months 3 and 12

• Change in time to onset of angina during ETT

  Months 3, 6 and 12

• Change in angina frequency and nitroglycerin

  Months 3 and 6

Study Arms (3)

1

EXPERIMENTAL

Genetic: Ad5FGF-4

2

EXPERIMENTAL

Genetic: Ad5FGF-4

3

PLACEBO COMPARATOR

Genetic: Placebo

Interventions

Ad5FGF-4 GENETIC

Adenovirus serotype-5 mediated human fibroblast growth factor-4 gene transfer

1; 2

Placebo GENETIC

Control group

3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients 18-75 years of age inclusive
• Stable angina classified as CCS III or IV
• Receiving treatment with at least two classes of chronic anti-anginal medication, of which two are at the maximally tolerated dose
• Left ventricular ejection fraction (LVEF) of ≥30%
• Not a candidate for, or unlikely to benefit from standard revascularization procedures as verified by an independent cardiologist or cardiothoracic surgeon (not a study investigator) at each center
• Can undergo ETT using the modified Bruce protocol and;
• ECG changes diagnostic of myocardial ischemia occur during the first 10 minutes of exercise
• Variability of the time to onset of ECG changes diagnostic of myocardial ischemia is ≤25% or within 60 seconds if the time to onset of myocardial ischemia occurs within the first 4 minutes of exercise as determined by two consecutive screening treadmill tests
• Evidence of stress induced myocardial ischemia by adenosine SPECT, defined as a reversible perfusion defect size of ≥9%
• Willing and able to comply with the study requirements including long-term follow-up
• Provided written informed consent

You may not qualify if:

• Patients of childbearing potential (must be surgically sterile or post-menopausal)
• Patients for whom an immediate revascularization procedure is indicated (CABG surgery or PCI)
• Myocardial infarction within the past 3 months
• Unstable angina or hospitalization requiring intravenous anti-anginal therapy within the 14 days prior to the start of screening evaluations
• Congestive heart failure NYHA Class IV
• Electrocardiogram that precludes accurate assessment of exercise induced myocardial ischemia (e.g., left bundle branch block, Wolf-Parkinson-White syndrome, atrial fibrillation)
• Myocarditis or restrictive pericarditis
• Left main coronary stenosis ≥70% (unless the patient has a patent graft or collateral vessels supplying the left coronary circulation) or proximal stenoses ≥70% in all major coronary conduit vessels (coronary arteries and bypass grafts)
• Clinically significant aortic or mitral valvular heart disease
• Coronary ostial stenosis that precludes adequate catheter engagement in any target vessel
• Coronary artery to venous communications, which bypass the coronary capillary bed
• Untreated life-threatening ventricular arrhythmias
• CABG surgery within the past 6 months, unless those grafts are now occluded.
• Percutaneous transluminal angioplasty (PTCA) within the past 3 months, unless the dilated vessel(s) are now occluded
• Enhanced external counterpulsation (EECP) within 3 months prior to the start of screening evaluations

Sponsors & Collaborators

• Cardium Therapeutics: lead

Study Sites (47)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Banner Heart Hospital

Phoenix, Arizona, 85206, United States

Location

Southwest Heart

Tucson, Arizona, 85715, United States

Location

Access Clinical Trials

Beverly Hills, California, 90210, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Mission Internal Medical Group

Mission Viejo, California, 92691, United States

Location

UCSD Medical Center

San Diego, California, 92103, United States

Location

Aurora Denver Cardiology

Aurora, Colorado, 80012, United States

Location

South Denver Cardiology

Littleton, Colorado, 80120, United States

Location

Cardiovascular Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

St Joseph's Research Institute

Atlanta, Georgia, 30342, United States

Location

St. Luke's Idaho Cardiology Associates

Boise, Idaho, 83712, United States

Location

Fox Valley Cardiovascular Consultants

Aurora, Illinois, 60504, United States

Location

Midwest Heart Foundation

Lombard, Illinois, 60148, United States

Location

Northern Indiana Research Alliance

Fort Wayne, Indiana, 46804, United States

Location

The Care Group

Indianapolis, Indiana, 46290, United States

Location

Cardiovascular Associates

Louisville, Kentucky, 40205, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

St. Mary's Duluth Clinic

Duluth, Minnesota, 55805, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

St. Anthony's Medical Center

St Louis, Missouri, 63128, United States

Location

BryanLGH Heart Institute

Lincoln, Nebraska, 68506, United States

Location

Creighton University

Omaha, Nebraska, 68131, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Lenox Hill Heart & Vascular Institute

New York, New York, 10021, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

The Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

North Ohio Heart Center

Elyria, Ohio, 44035, United States

Location

Oklahoma Cardiovascular Associates

Oklahoma City, Oklahoma, 73109, United States

Location

Providence Heart & Vascular Institute

Portland, Oregon, 97225, United States

Location

Heritage Cardiology Associates

Camp Hill, Pennsylvania, 17011, United States

Location

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

The Stern Cardiovascular Center

Germantown, Tennessee, 38138, United States

Location

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

Baylor University Medical Center at Dallas

Dallas, Texas, 75226, United States

Location

South Texas Cardiovascular Consultants

San Antonio, Texas, 78229, United States

Location

Cardiovascular Associates of East Texas

Tyler, Texas, 75701, United States

Location

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Care Foundation

Wausau, Wisconsin, 54401, United States

Location

Related Publications (1)

• Henry TD, Grines CL, Watkins MW, Dib N, Barbeau G, Moreadith R, Andrasfay T, Engler RL. Effects of Ad5FGF-4 in patients with angina: an analysis of pooled data from the AGENT-3 and AGENT-4 trials. J Am Coll Cardiol. 2007 Sep 11;50(11):1038-46. doi: 10.1016/j.jacc.2007.06.010. Epub 2007 Aug 24.

  PMID: 17825712 DERIVED

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Engler, MD

  Cardium Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2007
• First Posted: February 22, 2007
• Study Start: May 1, 2007
• Primary Completion: November 1, 2009
• Last Updated: February 13, 2013

Record last verified: 2008-11

Locations

US (47)