Ireland
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Recruiting Observational

A Clinical Study of Evaluating Myocardial Viability in Ischemic Heart Disease with Integrated 18F-FDG PET/MR

NCT06712862 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2025-12-31
Last updated
2024-12-02

Condition(s) studied

Ischemic Heart Disease

Study summary

The main purpose is to evaluate the accuracy of myocardial imaging obtained through integrated 18F-FDG PET/MR in detecting viable myocardium. The secondary objective is to evaluate whether myocardial imaging obtained through integrated 18F-FDG PET/MR can replace 18F-FDG PET combined with 99mTc MIBI SPECT/CT gated myocardial perfusion imaging.

Eligibility

Sex
ALL
Min age
—
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Myocardial perfusion tomographic imaging — After the patient signs the informed consent form and completes the scan, an average of 2 days.
    In accordance with the guidelines established by the American Heart Association, the left ventricular myocardium is segmented into 17 distinct regions and subjected to visual assessment for the identification of reversible myocardial perfusion abnormalities or defects.
  • Myocardiac metabolic Imaging — After the patient signs the informed consent form and completes the scan, an average of 2 days.
    In accordance with the guidelines established by the American Heart Association, the left ventricular myocardium is partitioned into 17 segments, which are subsequently assessed for the presence of diminished myocardial FDG uptake.

Trial sites (1)

FacilityCityRegionStatus
Shanghai East Hospital Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06712862 on ClinicalTrials.gov ↗ ← All trials in China