Ad-HGF Treatment for Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02844283
• Other study ID #: 2016-6-29
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: June 29, 2016
• Last updated: July 21, 2016
• Start date: November 2016

Study information

• Verified date: June 2016
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: First affiliated hospital of nanjing medical university
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Ad-HGF

Other:
• 0.9% NaCl

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of cardiac left ventricular ejection fraction (LVEF, %)	the difference of LVEF before and after treatment between groups.	Baseline to 6 months	No
Secondary	Quality of Life Measures (SF-36)	Participants will complete SF-36 to measure quality of life at baseline, 3 and 6 months.	Baseline to 6 months	No
Secondary	Activity Status (DASI)	Participants will complete DASI questionnaires to measure activity status at baseline, 3 and 6 months.	Baseline to 6 months	No
Secondary	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.	Baseline to 24 hours post delivery.	Yes
Secondary	changes of troponin (µg/L) within 24 hours post delivery.	the difference of troponin (µg/L) before and after delivery within 24 hours	Baseline to 24 hours post delivery.	Yes
Secondary	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.	Baseline to 1 week post delivery.	Yes
Secondary	number of participants with clinically significant changes in ECG than before	number of participants with clinically significant changes in ECG than before	Baseline to 6 months	Yes
Secondary	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	Baseline to 6 months	Yes
Secondary	number of participants with revascularization procedures during follow-up	number of participants with revascularization procedures during follow-up	Baseline to 6 months	Yes