Clinical trial NCT06712862: A Clinical Study of Evaluating Myocardial Viability in Ischemic Heart Disease with Integrated 18F-FDG PET/MR
Official title: A Clinical Study of Evaluating Myocardial Viability in Ischemic Heart Disease with Integrated 18F-FDG PET/MR
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Heart Disease
Keywords: PET/CMR
Ischemic Heart Disease
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 100
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who meet the inclusion and exclusion criteria and are willing to follow the research process.

Brief 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.

Detailed description: A comprehensive evaluation of the degree of coronary artery stenosis, myocardial ischemia range, and survival status are required before surgery, which can help predict postoperative efficacy and select the best treatment plan. Only when the heart muscle is alive, can the myocardial blood flow return to normal after revascularization surgery, improving left ventricular ejection fraction (LVEF) and long-term survival rate of patients. Performing coronary artery bypass grafting(CABG) on patients with lack of myocardial activity not only cannot benefit them, but also increases the risk of surgery. At present, the combination of 18F-flurodeoxyglucose(FDG) Positron Emission Tomography/ Computed Tomography(PET/CT) imaging and myocardial perfusion imaging is the most commonly used method in clinical practice to determine myocardial activity based on the matching of metabolism and blood flow. In recent years, the value of Cardiovascular Magnetic Resonance(CMR) in ischemic diagnosis and myocardial infarction assessment has been widely clinically validated, and many techniques in CMR have been included in clinical guidelines. Late Gadolinium Enhancement(LGE) imaging is the most accurate non-invasive technique for evaluating myocardial scars currently. Integrated Positron Emission Tomography/Magnetic Resonance imaging(PET/MR) can simultaneously evaluate myocardial perfusion, metabolism, vitality, and function, which has certain value for the diagnosis of myocardial ischemia and clinical prognosis of revascularization surgery.

Eligibility 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

Primary outcomes:
measure: Myocardial perfusion tomographic imaging
timeFrame: After the patient signs the informed consent form and completes the scan, an average of 2 days.
measure: Myocardiac metabolic Imaging
timeFrame: After the patient signs the informed consent form and completes the scan, an average of 2 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
References: