Ischemic Heart DiseaseNCT06712862
A Clinical Study of Evaluating Myocardial Viability in Ischemic Heart Disease with Integrated 18F-FDG PET/MR
An observational study of Ischemic Heart Disease, run by Shanghai East Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Ischemic Heart Disease
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2025to 31 Dec 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who meet the inclusion and exclusion criteria and are willing to follow the research process.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
About this study
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.
Read the 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.
- Conditions
- Ischemic Heart Disease
- Keywords
- PET/CMR, Ischemic Heart Disease
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After the patient signs the informed consent form and completes the scan, an average of 2 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start31 Dec 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712862
- Sponsor's protocol ID
- 2022097
- Status last verified
- Nov 2024
- First submitted
- 27 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect patient privacy, we will not share data. But if the researcher has reasonable reasons, they can apply to the research leader via email.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Evaluating Myocardial Viability in Ischemic Heart Disease with Integrated 18F-FDG PET/MR
- ClinicalTrials.gov ID
- NCT06712862
- Acronym / sponsor ID
- 2022097
- Conditions
- Ischemic Heart Disease
- Keywords
- PET/CMR, Ischemic Heart Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who meet the inclusion and exclusion criteria and are willing to follow the research process.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Myocardial perfusion tomographic imaging
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: No. To protect patient privacy, we will not share data. But if the researcher has reasonable reasons, they can apply to the research leader via email.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease, run by Shanghai East Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Zhao, Professor (13816137450 ext. +86 38804518, petcenter@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial perfusion tomographic imaging (time frame: After the patient signs the informed consent form and completes the scan, an average of 2 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.