Myocardial InfarctionPhase 1/2NCT02844283
Ad-HGF Treatment for Myocardial Infarction
A Phase 1/2 study testing Ad-HGF and 0.9% NaCl in people with Myocardial Infarction, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
This will be the first clinical trial use Ad-HGF gene for the treatment of myocardial infarction disease. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Ad-HGF and 0.9% NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Jul 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
Official title: 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.
- Conditions
- Myocardial Infarction
- Being tested
- Ad-HGF, 0.9% NaCl
- Keywords
- HGF,myocardial infarction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad-HGFDrug
0.9% NaClOther
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Single dose of Ad-HGF given by investigator via intracoronary injection into infarct-related artery Receives: 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 Receives: Other: 0.9% NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of cardiac left ventricular ejection fraction (LVEF, %)
the difference of LVEF before and after treatment between groups.
Measured: Baseline to 6 months
Secondary outcomes (8)
Quality of Life Measures (SF-36)
Participants will complete SF-36 to measure quality of life at baseline, 3 and 6 months.
Measured: Baseline to 6 months
Activity Status (DASI)
Participants will complete DASI questionnaires to measure activity status at baseline, 3 and 6 months.
Measured: Baseline to 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.
Measured: Baseline to 24 hours post delivery.
changes of troponin (μg/L) within 24 hours post delivery.
the difference of troponin (μg/L) before and after delivery within 24 hours
Measured: Baseline to 24 hours post delivery.
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.
Measured: Baseline to 1 week post delivery.
number of participants with clinically significant changes in ECG than before
number of participants with clinically significant changes in ECG than before
Measured: Baseline to 6 months
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
Measured: Baseline to 6 months
number of participants with revascularization procedures during follow-up
number of participants with revascularization procedures during follow-up
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startNov 2016
- Primary completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844283
- Sponsor's protocol ID
- 2016-6-29
- Status last verified
- Jun 2016
- First submitted
- 29 Jun 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenovirus Carrying Hepatocyte Growth Factor (Ad-HGF) Treatment for Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02844283
- Acronym / sponsor ID
- 2016-6-29
- Conditions
- Myocardial Infarction
- Keywords
- HGF,myocardial infarction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jul 2018 (estimated)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be the first clinical trial use Ad-HGF gene for the treatment of myocardial infarction disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Ad-HGFSingle dose of Ad-HGF given by investigator via intracoronary injection into infarct-related artery |
| control group | Sham comparator | Other: 0.9% NaCl0.9% sodium chloride (NaCl) injection of same volume given by investigator via intracoronary injection into infarct-related artery |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female 18-80 years of age
Key exclusion criteria (19 listed)
- Significant unprotected left main disease (stenosis of 50% or greater)on diagnostic angiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ad-HGF | Drug | treatment group |
| 0.9% NaCl | Other | control group |
Primary outcome
changes of cardiac left ventricular ejection fraction (LVEF, %)
Time frame: Baseline to 6 months
the difference of LVEF before and after treatment between groups.
8 secondary outcomes
Quality of Life Measures (SF-36)
Time frame: Baseline to 6 months
Activity Status (DASI)
Time frame: Baseline to 6 months
changes of creatinine kinase (CK, U/L) within 24 hours post delivery.
Time frame: Baseline to 24 hours post delivery.
changes of troponin (μg/L) within 24 hours post delivery.
Time frame: 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 clinically significant changes in ECG than before
Time frame: 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 revascularization procedures during follow-up
Time frame: Baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ad-HGF and 0.9% NaCl in people with Myocardial Infarction, run by The First Affiliated Hospital with Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of cardiac left ventricular ejection fraction (LVEF, %) (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.