Safety and Efficacy of Intracoronary Ad-HGF Administration for Treating Severe Coronary Disease: Results From Long-Term Follow-Up of a Phase I Clinical Trial
Journal Title: UNKNOWN - Year 2017, Vol 7, Issue 4
Abstract
Objective: This study is a long-term follow-up of our previous phase I clinical trial and aims at evaluating the long-term safety and efficacy of intracoronary Ad-HGF administration for treating coronary disease. Methods: This study includes 22 patients (11 in the experiment group and 11 in the control group) with diffused and severe coronary disease who had received the optimal standardized medication therapy and was not amenable to revascularization. Intracoronary Ad-HGF gene transfer was administered to the distal part of the accessible artery by over-the wire balloon or at the ostium of the target vessels by diagnostic coronary catheter in the experiment group. Safety parameters were measured and compared between baseline and follow-ups (5-week; 12-month; 36- month) only in the experiment group. The changes of efficacy parameters (ejection fraction, EF) from baseline to 36- month follow-up (δEF) were measured in both groups and compared with each other. Results: This study confirmed the long-term safety of intracoronary Ad-HGF administration for treating severe diffuse coronary disease. All the eleven patients of the experiment group were alive after 36-months follow-up. During the follow-up, no new-onset arrhythmia was recorded; no malignant tumor was diagnosed; no paroxysmal or long-term fever was recorded; no retinal vascular anomaly was diagnosed. There were no statistically significant differences between the follow-ups and baseline in regard to blood parameters, including WBC, Hb, ALT, AST, BUN, Cr, CEA and AFP. In addition, intracoronary Ad-HGF efficiently improved echocardiographic EF at the 36-month follow-up compared to baseline (F=4.4, p=0.024) and with the control group (δEF: 3.5 ± 1.1 vs. -4.5 ± 1.3, MD: 8, p=0.0001). The medium-high dose subgroup also showed higher ECT-EF at the 36-month follow-up than baseline (MD: 4.8, p=0.017, n=8) and higher improvement of ECT-EF than the control group (δEF: 4.8 ± 1.5 vs. 0.3 ± 1.7, MD: 4.5, p=0.08). Conclusion: Intracoronary Ad-HGF administration is safe and potentially efficient in improving EF of patients with severe diffuse coronary disease in 3-year follow-up
Authors and Affiliations
Qingzhe Jia, Zhijian Yang
Keywords
Related Articles
- EP ID EP386728
- DOI 10.4172/2167-0870.1000322
- Views 51
- Downloads 0
Design of a Multicenter, Randomized, Open Label, Parallel Group Study to Evaluate the Efficacy of Loxoprofen on Acute-Phase Reactions in Japanese Primary Osteoporosis Patients Treated with Zoledronic Acid
Treatment of osteoporosis with once-yearly zoledronic acid was approved in September 2016 in Japan. Like other bisphosphonates, zoledronic acid causes acute-phase responses (APRs), which are more severe in Asian populati...
The ANQueSt (Asian Nurse Quality of life Study) to Compare Quality of Life and Identify Related Variables: Study Protocol for a Cross-Sectional Design
Background: Hospital-based nurses’ quality of life is affected by stress coping ability, job satisfaction, job stress, and social support. These relationships appear to be identical, even among different countries. Never...
Effectiveness of Moxibustion Combined with Conventional Treatment for Moderate-Severe Persistent Allergic Rhinitis: Protocol for a Randomized, Controlled Trial
Introduction: The incidence of allergic rhinitis (AR) has risen dramatically in recent years, and presents with higher symptom frequency, affecting quality of life. Clinical research shows that conventional medical treat...
Preparation with Mechanical Bowel Cleansing or/and Oral Antibiotics or Nothing for Elective Colorectal Surgery: Two-Two-Arm Multicentre Randomised Controlled Studies (MECCLANT –C and –R Trials)
Background: Based on sound evidence, traditional mechanical bowel preparation for elective colorectal surgery has mostly been abandoned during the last two decades. However, more recent evidence from USA large databases...
Early Treadmill ECG Stress Testing After Percutaneous Coronary Intervention Following Hemostasis with the Angioseal™ Vascular Closure Device: A Prospective Single-Center Cohort Study
Objective: Particularly with the transfemoral access, potential complications at the puncture site with early exercise are a major concern. The purpose of this study was to compare femoral artery access site complication...