Evaluating heart muscle viability in patients with ischemic heart disease using advanced imaging techniques
A Clinical Study of Evaluating Myocardial Viability in Ischemic Heart Disease with Integrated 18F-FDG PET/MR
This study is testing a new imaging method to see if it can better identify healthy heart muscle in patients with ischemic heart disease compared to the traditional imaging techniques before they have heart surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | N/A to 80 Years |
| Sex | All |
| Sponsor | Shanghai East Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06712862 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of integrated 18F-FDG PET/MR imaging in detecting viable heart muscle in patients with ischemic heart disease. It compares this method to the traditional combination of 18F-FDG PET and 99mTc MIBI SPECT/CT imaging to determine if the newer approach can serve as a replacement. The study will involve evaluating coronary artery stenosis, myocardial ischemia, and survival status prior to surgical interventions, which is crucial for optimizing treatment plans. The goal is to ensure that only patients with viable myocardium undergo revascularization procedures, thereby improving outcomes and reducing surgical risks.
Who should consider this trial
Good fit: Ideal candidates are adults under 80 with significant coronary artery disease and reduced left ventricular ejection fraction.
Not a fit: Patients with poorly controlled diabetes, certain electronic implants, or recent aneurysm surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments of heart muscle viability, improving treatment decisions and patient outcomes in ischemic heart disease.
How similar studies have performed: While integrated imaging techniques are gaining traction, this specific approach using 18F-FDG PET/MR for myocardial viability assessment is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults under the age of 80 2. Coronary angiography shows coronary artery disease, with at least 2 coronary arteries having a degree of stenosis greater than 80% 3. ft ventricular ejection fraction (LVEF)\<40% 4. Acute myocardial infarction onset for at least 3 months 5. Patients with old myocardial infarction with no acute coronary artery events in the past 3 months 6. Patients of pre implementation of coronary artery bypass grafting (CABG) or combined treatment with human umbilical cord mesenchymal stem cells (iPSC) 7. Agree to participate in this clinical trial and sign an informed consent form 8. Good compliance Exclusion Criteria: * 1.Patients with diabetes or other patients with poor blood glucose control (fasting blood glucose value on the test day is greater than 10mmol/L) 2.Patients who allergy to MR contrast agent 3.Electronic implants such as pacemakers, nerve stimulators, insulin pumps, cochlear implants 4.Patients who have undergone aneurysm surgery and have intracranial aneurysm clips 5.Patients who have undergone heart surgery and have an artificial heart valve 6.Patients with metal foreign objects in the eyes 7.Patients with metal implants and prostheses, or metal foreign bodies in other parts of body 8.Severe liver and kidney dysfunction 9.Accompanied by arrhythmia such as atrial fibrillation, cerebrovascular disease, and severe pulmonary heart disease 10.Pregnant or plan to pregnant within three months or lactating women 11.Critically ill patients who require the use of life support systems 12.Patients with claustrophobia 13.Other situations which clinical trial personnel deem it inappropriate to participate in this trial
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jun Zhao, Professor
- Email: petcenter@126.com
- Phone: 13816137450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.