Ad-HGF Treatment for Myocardial Infarction

NCT02844283 | Unknown Phase 1

• 1 other identifier: 2016-6-29
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Myocardial Infarction

Keywords

HGF,myocardial infarction

Outcome Measures

Primary Outcomes (1)

• changes of cardiac left ventricular ejection fraction (LVEF, %)

  the difference of LVEF before and after treatment between groups.

  Baseline to 6 months

Secondary Outcomes (8)

• Quality of Life Measures (SF-36)

  Baseline to 6 months

• Activity Status (DASI)

  Baseline to 6 months

• changes of creatinine kinase (CK, U/L) within 24 hours post delivery.

  Baseline to 24 hours post delivery.

• changes of troponin (μg/L) within 24 hours post delivery.

  Baseline to 24 hours post delivery.

• number of participants with evidence of any systemic embolization within 1 week post delivery.

  Baseline to 1 week post delivery.

Study Arms (2)

treatment group

EXPERIMENTAL

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

Drug: Ad-HGF

control group

SHAM COMPARATOR

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

Other: 0.9% NaCl

Interventions

Ad-HGF DRUG

treatment group

0.9% NaCl OTHER

control group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 26, 2016
• Study Start: November 1, 2016
• Primary Completion: July 1, 2018
• Last Updated: July 26, 2016

Record last verified: 2016-06