Clinical trial NCT02844283: Ad-HGF Treatment for Myocardial Infarction
Official title: Adenovirus Carrying Hepatocyte Growth Factor (Ad-HGF) Treatment for Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Myocardial Infarction
Keywords: HGF,myocardial infarction
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: changes of cardiac left ventricular ejection fraction (LVEF, %)
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Quality of Life Measures (SF-36)
timeFrame: Baseline to 6 months
measure: Activity Status (DASI)
timeFrame: Baseline to 6 months
measure: changes of creatinine kinase (CK, U/L) within 24 hours post delivery.
timeFrame: Baseline to 24 hours post delivery.
measure: changes of troponin (μg/L) within 24 hours post delivery.
timeFrame: Baseline to 24 hours post delivery.
measure: number of participants with evidence of any systemic embolization within 1 week post delivery.
timeFrame: Baseline to 1 week post delivery.
measure: number of participants with clinically significant changes in ECG than before
timeFrame: Baseline to 6 months
measure: number of participants with major acute cardiac events (cardiac death and myocardial infarction) during follow-up
timeFrame: Baseline to 6 months
measure: number of participants with revascularization procedures during follow-up
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
Study officials:
References: