Safety and Efficacy of Intracoronary Ad5FGF-4 in Patients With Stable Angina

Cardium Therapeutics116 enrolled

Overview

The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4 is effective in improving exercise capacity measured by exercise treadmill testing, angina functional class, patient symptoms, quality of life, and cardiovascular outcomes. To doses are to be studied, 2.87x10(8) and 2.87x10(9) viral particles, to evaluate the dose-response of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

116

Conditions

Stable Angina

Interventions

AdF5FGF-4 vs. PlaceboGENETIC

Intracoronary infusion

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * CCS class II - IV, technically unsuitable for revascularization by CABG or PTCA able to exercise between 3 and 10 minutes on treadmill Exclusion Criteria: * Unstable angina, CCS class 1 angina optimal candidates for revascularization

Outcomes

Primary Outcomes

Treadmill exercise duration

Time frame: Week 12

Secondary Outcomes

Time to coronary events

Time frame: 1 Year

Data from ClinicalTrials.gov

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