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Efficacy and Safety of Ad5FGF-4 for Myocardial Ischemia in Patients With Stable Angina Due to Coronary Artery Disease

NCT01550614 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2016-09-29

No results posted yet for this study

Summary

The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4, delivered during induced transient ischemia, is effective in improving myocardial perfusion, angina functional class, patient symptoms, and quality of life. Short-term (8 weeks) and long-term (12 month) safety of Ad5FGF-4 will also be evaluated. The primary endpoint is change in adenosine triphosphate (ATP) stress SPECT reperfusion defect size.

Conditions

  • Angina, Stable

Interventions

GENETIC

Alferminogene tadenovec

One-time intracoronary infusion of Ad5FGF-4 (6x10e9 viral particles in buffer)

Sponsors & Collaborators

  • Advanced Biosciences Research

    collaborator UNKNOWN

  • Cardium Therapeutics

    lead INDUSTRY

Principal Investigators

  • Gabor Rubanyi · Cardium Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2016-05-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01550614 on ClinicalTrials.gov