Ad-HGF Treatment for Myocardial Infarction

NCT ID: NCT02844283

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30

Brief Summary

This will be the first clinical trial use Ad-HGF gene for the treatment of myocardial infarction disease.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

treatment group

Single dose of Ad-HGF given by investigator via intracoronary injection into infarct-related artery

Group Type: EXPERIMENTAL

Ad-HGF

Intervention Type: DRUG

control group

0.9% sodium chloride (NaCl) injection of same volume given by investigator via intracoronary injection into infarct-related artery

Group Type: SHAM_COMPARATOR

0.9% NaCl

Intervention Type: OTHER

Interventions

Ad-HGF

Intervention Type: DRUG

0.9% NaCl

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male or female 18-80 years of age

• Clinical diagnosis of anterior ST-segment elevation myocardial infarction (STEMI) within the last 30 days, with any one of the following 12-lead electrocardiographic changes:
• a) Greater than or equal to 2 mm ST-segment elevation) in 2 adjacent electrocardiographic precordial leads
• b) A new left bundle branch block AND and an increase in cardiospecific enzymes >3x CK, or increase in troponin compared to institution laboratory normal ranges
• Successful PCI with stent implantation to infarct-related artery within the last 30 days; defined as residual stenosis no greater than 30%, Thrombolysis In Myocardial Infarction (TIMI) flow of at least 2 and a reference diameter of at least > 2mm
• Is considered hemodynamically stable at time of enrollment and immediately prior to Ad-HGF delivery
• Screening LVEF for the first 12 enrolled participants, must be no greater than 40% by echocardiography (determined by Simpson's method) performed at least 2 days after revascularization procedure. Subsequent participants enrolled in the trial, must have an LVEF no greater than 45%. (All screening echos done within the first 4 days post percutaneous coronary intervention (PCI) must be repeated either by echocardiography or MRI prior to Ad-HGF delivery to ensure that the variability does not exceed 10%)
• In the case of a previous myocardial infarction, documented LVEF must be 50% or greater
• Female participants must be surgically sterile, post-menopausal, have documented infertility, or are of child-bearing potential wih laboratory confirmation of non-pregnant state
• Provided written informed consent and is willing to comply with study follow-up visits

Exclusion Criteria

• Significant unprotected left main disease (stenosis of 50% or greater)on diagnostic angiography

• An increase in LVEF by greater that 10% from initial LVEF evaluation for repeat assessments
• The presence of significant coronary lesions, other than the index lesion of the infarction related artery
• A history of significant ventricular arrhythmia not related to index STEMI
• A history of cerebro-vascular accident or transient ischemic attack within 6 months of enrollment
• Inability to undergo apheresis procedure(i.e.: poor venous access, laboratory abnormalities
• A history of uncorrected significant valvular heart disease
• A history of left ventricular dysfunction prior to index STEMI
• A history of human immunodeficiency virus (HIV)or hepatitis B or C infection
• A history of malignancy within 5 years (Except for low-grade and fully resolved non-melanoma skin cancer)
• A history of allergy to gentamycin or amphotericin
• A history of non-compliance
• Active inflammatory autoimmune disease requiring chronic immunosuppressive therapy
• Creatinine clearance <60 by Cockcroft-Gault Calculator
• Confirmed pregnant or lactating
• Is enrolled in a current investigational drug or device trial
• Participant has received cell or gene therapy in past
• The presence of any significant co-morbidities that, in the investigator's opinion, would preclude the participant from taking part in the trial
• Inability to provide informed consent and comply with the follow-up visit schedule

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2016-6-29

Identifier Type: -

Identifier Source: org_study_id