Actively Recruiting
Evaluating Myocardial Viability in Ischemic Heart Disease Using Integrated 18F-FDG PET/MR Imaging
Led by Shanghai East Hospital · Updated on 2024-12-02
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy of myocardial imaging using integrated 18F-FDG PET/MR to detect viable heart muscle in patients with ischemic heart disease. The study also aims to see if this imaging method can replace the current standard that combines 18F-FDG PET with 99mTc MIBI SPECT/CT gated myocardial perfusion imaging. This is important as assessing heart muscle viability helps predict treatment success and select the best surgical options, especially before coronary artery bypass grafting (CABG). Participants will undergo two procedures within two weeks before surgery: an integrated 18F-FDG PET/MR scan, and a combined 18F-FDG PET/MR plus 99mTc MIBI gated myocardial perfusion imaging. These imaging techniques allow doctors to evaluate heart blood flow, metabolism, muscle vitality, and function simultaneously. The study focuses on patients with significant coronary artery narrowing and reduced heart function, some of whom may also receive stem cell treatments alongside CABG. During the study, participants will sign informed consent and complete the imaging scans, with outcome measures including myocardial perfusion and metabolic imaging assessed approximately two days after the scans. Researchers will monitor heart function and muscle viability to help determine surgical outcomes. The study runs until 2026 and involves adults under 80 years with specific heart conditions, ensuring comprehensive assessments to support future heart disease treatments.
CONDITIONS
Brief Title
A Clinical Study of Evaluating Myocardial Viability in Ischemic Heart Disease with Integrated 18F-FDG PET/MR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults under the age of 80
- Coronary angiography shows coronary artery disease with at least two arteries having stenosis greater than 80%
- Left ventricular ejection fraction (LVEF) less than 40%
- Acute myocardial infarction onset at least 3 months prior
- Patients with old myocardial infarction without acute coronary events in the past 3 months
- Patients scheduled for coronary artery bypass grafting (CABG) or combined treatment with human umbilical cord mesenchymal stem cells (iPSC)
- Agree to participate and sign informed consent
- Good compliance
You will not qualify if you...
- Patients with diabetes or poor blood glucose control (fasting blood glucose above 10 mmol/L on test day)
- Allergy to MR contrast agent
- Presence of electronic implants such as pacemakers, nerve stimulators, insulin pumps, or cochlear implants
- Previous aneurysm surgery with intracranial aneurysm clips
- Previous heart surgery with artificial heart valve
- Metal foreign objects in the eyes
- Metal implants, prostheses, or foreign bodies elsewhere in the body
- Severe liver or kidney dysfunction
- Arrhythmias such as atrial fibrillation, cerebrovascular disease, or severe pulmonary heart disease
- Pregnant or planning pregnancy within three months, or lactating women
- Critically ill patients needing life support
- Claustrophobia
- Other conditions deemed inappropriate by clinical trial personnel
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 2 weeks before surgery
Participants undergo integrated 18F-FDG PET/MR scans, with some also receiving additional gated myocardial perfusion imaging, to evaluate myocardial viability before surgery.
1 to 2 visits depending on group assignment
Duration - Average of 2 days after imaging
Participants are observed for myocardial perfusion and metabolic changes following the imaging assessments to help predict surgical outcomes.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
Research Team
J
Jun Zhao, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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