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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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