Ischemic heart disease
Conditions
Interventions
A single application of gelatin hydrogel sheet incorporating with 200 ug of basic fibroblast growth factor (bFGF) To assess the adverse effect within 24 weeks after the treatment
Sponsors
Kyoto University Graduate School of Medicine Department of Cardiovascular Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Candidates for coronary artery bypass grafting, with or without concomitant procedures, under the diagnosis of ischemic heart disease 2) Patients who have ischemic and viable myocardium, proved by echocardiography, MRI, and cardiac scintigraphy (99mTc-Tetrofosmin-single photon emission computed tomography : 99mTc-TF SPECT) 3) Patients who have myocardium which is not suitable to be bypassed at least one of the three major coronary territories 4) Age between 20 and 80 years old at the enrollment 5) Informed consent is obtained 6) Patients who are judged suitable for the study by the principal investigator and other investigators
Exclusion criteria
Exclusion criteria: 1) Emergency case 2) Diabetes mellitus with poor control (HbA1c>10%) 3) Poor prognosis with life expectancy <1 year 4) Recent (within 3 months) medical history such as myocardial infarction, stroke, transient ischemic attach, and severe allergic reactions. Alcoholic abuse requiring medical treatment within 1 year 5) Diabetic retinopathy which is being treated. Of note, may be enrolled if ophthalmologist decide that the retinopathy can be cured by the time of application of bFGF. 6) Dependent on chronic hemodyalisis 7) Patients participating clinical study using bFGF or gene therapy in the past 8) Patients who have known history of malignancy within 5 years, of note, carcinoma in-situ is not included. 9) Pregnant or expecting pregnancy women. Men who wish his partner to be pregnant. 10) Patients who have hemodynamic instability before the application of bFGF gelatin hydrogel sheet, or who are thought to be high-risk for the treatment. 11) Patients in whom it is not safe or appropriate to conduct the study judged by the principal investigator or other investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the adverse effect and side effect within 24 weeks after the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess cardiac function and coronary perfusion within 24 weeks after the treatment using New York Heart Association (NYHA) functional class, Canadian Cardiovascular Society (CCS) class, coronary angiography, myocardial scintigraphy, echocardiography, and cardiac magnetic resonance imaging (MRI) | — |
Countries
Japan
Contacts
Public ContactAyaka Toya Yoko Tsukiyama
Kyoto University Graduate School of Medicine Department of Cardiovascular Surgery
Outcome results
None listed