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

NCT06712862 | Recruiting DMC

• 1 other identifier: 2022097
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease

Keywords

PET/CMR; Ischemic Heart Disease

Outcome Measures

Primary Outcomes (2)

• Myocardial perfusion tomographic imaging

  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.

  After the patient signs the informed consent form and completes the scan, an average of 2 days.

• Myocardiac metabolic Imaging

  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.

  After the patient signs the informed consent form and completes the scan, an average of 2 days.

Study Arms (2)

Research group

All patients will receive an integrated 18F-FDG PET/MR scan within 2 weeks before surgery.

Control Group

All patients will receive integrated 18F-FDG PET/MR plus 99mTc MIBI G-MPI (gated myocardial perfusion imaging) within 2 weeks before surgery.

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who meet the inclusion and exclusion criteria and are willing to follow the research process.

You may qualify if:

• Adults under the age of 80
• Coronary angiography shows coronary artery disease, with at least 2 coronary arteries having a degree of stenosis greater than 80%
• ft ventricular ejection fraction (LVEF)\<40%
• Acute myocardial infarction onset for at least 3 months
• Patients with old myocardial infarction with no acute coronary artery events in the past 3 months
• Patients of pre implementation of coronary artery bypass grafting (CABG) or combined treatment with human umbilical cord mesenchymal stem cells (iPSC)
• Agree to participate in this clinical trial and sign an informed consent form
• Good compliance

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Jun Zhao, Professor

CONTACT

13816137450; petcenter@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 2, 2024
• Study Start: December 31, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)