Ad-HGF Treatment for Myocardial Infarction
Primary Purpose
Myocardial Infarction
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ad-HGF
0.9% NaCl
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring HGF,myocardial infarction
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
treatment group
control group
Arm Description
Single dose of Ad-HGF given by investigator via intracoronary injection into infarct-related artery
0.9% sodium chloride (NaCl) injection of same volume given by investigator via intracoronary injection into infarct-related artery
Outcomes
Primary Outcome Measures
changes of cardiac left ventricular ejection fraction (LVEF, %)
the difference of LVEF before and after treatment between groups.
Secondary Outcome Measures
Quality of Life Measures (SF-36)
Participants will complete SF-36 to measure quality of life at baseline, 3 and 6 months.
Activity Status (DASI)
Participants will complete DASI questionnaires to measure activity status at baseline, 3 and 6 months.
changes of creatinine kinase (CK, U/L) within 24 hours post delivery.
the difference of creatinine kinase (CK, U/L) before and after delivery within 24 hours.
changes of troponin (μg/L) within 24 hours post delivery.
the difference of troponin (μg/L) before and after delivery within 24 hours
number of participants with evidence of any systemic embolization within 1 week post delivery.
number of participants with evidence of any systemic embolization during the hospitalization period post delivery.
number of participants with clinically significant changes in ECG than before
number of participants with clinically significant changes in ECG than before
number of participants with major acute cardiac events (cardiac death and myocardial infarction) during follow-up
number of participants with major acute cardiac events (cardiac death and myocardial infarction) during follow-up
number of participants with revascularization procedures during follow-up
number of participants with revascularization procedures during follow-up
Full Information
NCT ID
NCT02844283
First Posted
June 29, 2016
Last Updated
July 21, 2016
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02844283
Brief Title
Ad-HGF Treatment for Myocardial Infarction
Official Title
Adenovirus Carrying Hepatocyte Growth Factor (Ad-HGF) Treatment for Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
5. Study Description
Brief Summary
This will be the first clinical trial use Ad-HGF gene for the treatment of myocardial infarction disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
HGF,myocardial infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
Single dose of Ad-HGF given by investigator via intracoronary injection into infarct-related artery
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
0.9% sodium chloride (NaCl) injection of same volume given by investigator via intracoronary injection into infarct-related artery
Intervention Type
Drug
Intervention Name(s)
Ad-HGF
Intervention Type
Other
Intervention Name(s)
0.9% NaCl
Primary Outcome Measure Information:
Title
changes of cardiac left ventricular ejection fraction (LVEF, %)
Description
the difference of LVEF before and after treatment between groups.
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Quality of Life Measures (SF-36)
Description
Participants will complete SF-36 to measure quality of life at baseline, 3 and 6 months.
Time Frame
Baseline to 6 months
Title
Activity Status (DASI)
Description
Participants will complete DASI questionnaires to measure activity status at baseline, 3 and 6 months.
Time Frame
Baseline to 6 months
Title
changes of creatinine kinase (CK, U/L) within 24 hours post delivery.
Description
the difference of creatinine kinase (CK, U/L) before and after delivery within 24 hours.
Time Frame
Baseline to 24 hours post delivery.
Title
changes of troponin (μg/L) within 24 hours post delivery.
Description
the difference of troponin (μg/L) before and after delivery within 24 hours
Time Frame
Baseline to 24 hours post delivery.
Title
number of participants with evidence of any systemic embolization within 1 week post delivery.
Description
number of participants with evidence of any systemic embolization during the hospitalization period post delivery.
Time Frame
Baseline to 1 week post delivery.
Title
number of participants with clinically significant changes in ECG than before
Description
number of participants with clinically significant changes in ECG than before
Time Frame
Baseline to 6 months
Title
number of participants with major acute cardiac events (cardiac death and myocardial infarction) during follow-up
Description
number of participants with major acute cardiac events (cardiac death and myocardial infarction) during follow-up
Time Frame
Baseline to 6 months
Title
number of participants with revascularization procedures during follow-up
Description
number of participants with revascularization procedures during follow-up
Time Frame
Baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
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Ad-HGF Treatment for Myocardial Infarction
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