Ad-HGF Treatment for Myocardial Infarction

July 21, 2016 updated by: The First Affiliated Hospital with Nanjing Medical University

Adenovirus Carrying Hepatocyte Growth Factor (Ad-HGF) Treatment for Myocardial Infarction

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group
Single dose of Ad-HGF given by investigator via intracoronary injection into infarct-related artery
Drug: Ad-HGF
Sham Comparator: control group
0.9% sodium chloride (NaCl) injection of same volume given by investigator via intracoronary injection into infarct-related artery
Other: 0.9% NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of cardiac left ventricular ejection fraction (LVEF, %)
Time Frame: Baseline to 6 months
the difference of LVEF before and after treatment between groups.
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Measures (SF-36)
Time Frame: Baseline to 6 months
Participants will complete SF-36 to measure quality of life at baseline, 3 and 6 months.
Baseline to 6 months
Activity Status (DASI)
Time Frame: Baseline to 6 months
Participants will complete DASI questionnaires to measure activity status at baseline, 3 and 6 months.
Baseline to 6 months
changes of creatinine kinase (CK, U/L) within 24 hours post delivery.
Time Frame: Baseline to 24 hours post delivery.
the difference of creatinine kinase (CK, U/L) before and after delivery within 24 hours.
Baseline to 24 hours post delivery.
changes of troponin (μg/L) within 24 hours post delivery.
Time Frame: Baseline to 24 hours post delivery.
the difference of troponin (μg/L) before and after delivery within 24 hours
Baseline to 24 hours post delivery.
number of participants with evidence of any systemic embolization within 1 week post delivery.
Time Frame: Baseline to 1 week post delivery.
number of participants with evidence of any systemic embolization during the hospitalization period post delivery.
Baseline to 1 week post delivery.
number of participants with clinically significant changes in ECG than before
Time Frame: Baseline to 6 months
number of participants with clinically significant changes in ECG than before
Baseline to 6 months
number of participants with major acute cardiac events (cardiac death and myocardial infarction) during follow-up
Time Frame: Baseline to 6 months
number of participants with major acute cardiac events (cardiac death and myocardial infarction) during follow-up
Baseline to 6 months
number of participants with revascularization procedures during follow-up
Time Frame: Baseline to 6 months
number of participants with revascularization procedures during follow-up
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

June 29, 2016

First Submitted That Met QC Criteria

July 21, 2016

First Posted (Estimate)

July 26, 2016

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 21, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-6-29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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