Ischemic Heart Disease
Conditions
Keywords
ischemic heart disease, adenovirus, hepatocyte growth factor
Brief summary
To explore the safety and efficiency of adenovirus-hepatocyte growth factor(Ad-HGF) treatment in ischemic heart disease.
Detailed description
1. Ischemic heart disease refers to a group of closely related syndromes by an imbalance between the myocardial oxygen demand and the blood supply. 2. Gene therapy offers an attractive alternative to current pharmacologic therapies and may be beneficial in refractory disease. Gene therapy with hepatocyte growth factor induces angiogenesis, decreases apoptosis and leads to protection in the ischemic heart. In this study, we mainly explore the safety and effects of adenovirus hepatocyte growth factor for the treatment of ischemic heart disease.
Interventions
DRUGAd-HGF
5×10(9)pfu adenovirus hepatocyte growth factor was delivered by transendocardial injection into five left ventricular sites.
Sponsors
Academy Military Medical Science, China
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* person with ischemic heart disease; * Male or female of 20 to 70 years old; * No blood perfusion detected in some area of heart using Single-Photon Emission Computed Tomography(SPECT) or Magnetic Resonance Imaging(MRI) * two or more than two coronary arteries lesions were detected using coronary artery angiography and at least one coronary artery are un-suitable for percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG)；Or patients refuse to perform PCI or CABG * LVEF is ≤45%; * Patients must sign approved informed consent.
Exclusion criteria
* Acute myocardial infarction occured within one week * CABG performed within 6 months or PCI performed within 3 months * Patients with systemic active infection * Blood alanine aminotransferase (ALT)\>135mmol/L or blood crea(Cr)\>200umol/L or patients with chronic obstructive pulmonary disease (COPD) * patients with obvious bleeding tendency and blood disease * patients with malignant tumor or end-stage disease * patient anticipated life expectancy is less than 12 months * patient recently attended test drugs or other device research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with death,new myocardial infarction or stroke | 6 months after treatment |
Secondary
| Measure | Time frame |
|---|---|
| left ventricular ejection fraction (LVEF) | 6 months after treatment |
Other
| Measure | Time frame |
|---|---|
| tumor markers of blood | 6 months after treatment |
Countries
China
Contacts
Primary ContactDingguo Zhang, PhD.
Outcome results
None listed