Cardiac Magnetic Resonance ImagingNCT07130409
Multimodal Imaging Assessment After Revascularization in Patients With Acute Myocardial Infarction
An observational study of Cardiac Magnetic Resonance Imaging and Acute Myocardial Infarction (AMI), run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
This prospective cohort study will enroll 20 patients clinically diagnosed with first-time acute myocardial infarction (AMI) who underwent interventional procedures (including percutaneous coronary intervention [PCI] and balloon angioplasty) at the Affiliated Hospital of Qingdao University. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Magnetic Resonance Imaging, Acute Myocardial Infarction (AMI), PET / MR
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Aug 2025to 31 Dec 2026
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: clinically diagnosed with first-episode AMI and undergoing interventional therapy
Who may be able to join
- Patients with a clinical diagnosis of first-episode acute myocardial infarction (AMI) who underwent emergency percutaneous coronary intervention (PCI) were included. All patients had complete baseline clinical data, with baseline cardiac magnetic resonance (CMR) examinations performed within 7 days post-PCI and follow-up CMR completed at 6 months post-procedure.
Who cannot join
- Patients with severe cardiac decompensation (Killip class 4) or clinically unstable conditions.
- Patients with coexisting valvular heart disease, congenital heart disease, pulmonary hypertension, cardiomyopathy, or persistent atrial fibrillation that may confound cardiac structural/functional assessments.
- Prior history of myocardial infarction, coronary revascularization (PCI/CABG).
- Concurrent severe systemic diseases including hematologic disorders, malignancies, rheumatic/autoimmune diseases, or severe hepatic/renal failure.
- Contraindications to CMR (claustrophobia, pacemaker implantation, etc.).
- Pregnant, breastfeeding, or women of childbearing potential without effective contraception.
- Sexually active individuals of reproductive age unwilling to use reliable contraception.
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
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Pei Nie, 0532-82911500, niepei@qdu.edu.cn
About this study
This prospective cohort study will enroll 20 patients clinically diagnosed with first-time acute myocardial infarction (AMI) who underwent interventional procedures (including percutaneous coronary intervention [PCI] and balloon angioplasty) at the Affiliated Hospital of Qingdao University. Patient data, including routine blood and urine tests, blood biochemistry, electrocardiograms (ECG), imaging studies, and interventional procedure records, will be collected to assess eligibility for enrollment. The study procedures include patient screening and enrollment, obtaining informed consent, baseline assessment (including medical history, laboratory tests, ECG, etc.), an ¹⁸F-Pentixafor PET/MR examination, and follow-up. Images will be blindly assessed by at least two specialized physicians from the Radiology and Nuclear Medicine departments. The study aims to investigate the utility of ¹⁸F-Pentixafor PET/MR in evaluating coronary microcirculatory function, cardiac function, myocardial viability, myocardial inflammatory response, and the efficacy of interventional therapy in AMI patients post-procedure. Additionally, it will perform risk stratification and prognostic analysis for the enrolled patients.
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 |
|---|---|---|
| clinically diagnosed with first-episode AMI and undergoing interventional therapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The myocardial uptake of 18F-Pentixafor was quantified using SUVmax and SUVmean values derived from PET imaging.
Measured: At baseline (within 1 week of enrollment)
Left ventricular ejection fraction (LVEF) assessed by cardiac MRI to evaluate left ventricular function
Measured: At baseline (within 1 week of enrollment)
Infarct Characterization
Late gadolinium enhancement (LGE) images were used to calculate infarct size (IS).
Measured: At baseline (within 1 week of enrollment)
Secondary outcomes (3)
Myocardial T1 Values and Extracellular Volume (ECV)
Myocardial T1 values within the LGE territory were measured to yield native T1 and post-contrast T1 values. ECV was calculated using the native and post-contrast myocardial T1 values, blood pool T1 values, and the hematocrit (HCT).
Measured: At baseline (within 1 week of enrollment)
Myocardial T2 values
Myocardial T2 values were quantified using T2 mapping images to assess myocardial edema.
Measured: At baseline (within 1 week of enrollment)
Myocardial Strain Analysis
Feature-tracking analysis (CMR-FT module, CVI42) was performed offline on cine sequences. LV endocardial and epicardial contours were automatically tracked at end-diastole and end-systole, followed by manual adjustments as necessary. Global and segmental myocardial strain values were derived.
Measured: At baseline (within 1 week of enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2026 (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 Cardiac Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130409
- Sponsor's protocol ID
- QYFYECR2025-74
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Imaging Assessment After Revascularization in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07130409
- Acronym / sponsor ID
- QYFYECR2025-74
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Aug 2025 (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.
This prospective cohort study will enroll 20 patients clinically diagnosed with first-time acute myocardial infarction (AMI) who underwent interventional procedures (including percutaneous coronary intervention [PCI] and balloon angioplasty) at the Affiliated Hospital of Qingdao University. Patient data, including routine blood and urine tests, blood biochemistry, electrocardiograms (ECG), imaging studies, and interventional procedure records, will be collected to assess eligibility for enrollment. The study procedures include patient screening and enrollment, obtaining informed consent, baseline assessment (including medical history, laboratory tests, ECG, etc.), an ¹⁸F-Pentixafor PET/MR examination, and follow-up. Images will be blindly assessed by at least two specialized physicians from the Radiology and Nuclear Medicine departments. The study aims to investigate the utility of ¹⁸F-Pentixafor PET/MR in evaluating coronary microcirculatory function, cardiac function, myocardial viability, myocardial inflammatory response, and the efficacy of interventional therapy in AMI patients post-procedure. Additionally, it will perform risk stratification and prognostic analysis for the enrolled patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clinically diagnosed with first-episode AMI and undergoing interventional therapy | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- clinically diagnosed with first-episode AMI and undergoing interventional therapy
Key inclusion criteria (1 listed)
- Patients with a clinical diagnosis of first-episode acute myocardial infarction (AMI) who underwent emergency percutaneous coronary intervention (PCI) were included. All patients had complete baseline clinical data, with baseline cardiac magnetic resonance (CMR) examinations performed within 7 days post-PCI and follow-up CMR completed at 6 months post-procedure.
Key exclusion criteria (7 listed)
- Patients with severe cardiac decompensation (Killip class 4) or clinically unstable conditions.
- Patients with coexisting valvular heart disease, congenital heart disease, pulmonary hypertension, cardiomyopathy, or persistent atrial fibrillation that may confound cardiac structural/functional assessments.
- Prior history of myocardial infarction, coronary revascularization (PCI/CABG).
- Concurrent severe systemic diseases including hematologic disorders, malignancies, rheumatic/autoimmune diseases, or severe hepatic/renal failure.
- Contraindications to CMR (claustrophobia, pacemaker implantation, etc.).
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
The myocardial uptake of 18F-Pentixafor was quantified using SUVmax and SUVmean values derived from PET imaging.
Time frame: At baseline (within 1 week of enrollment)
Left ventricular ejection fraction (LVEF) assessed by cardiac MRI to evaluate left ventricular function
Time frame: At baseline (within 1 week of enrollment)
Infarct Characterization
Time frame: At baseline (within 1 week of enrollment)
Late gadolinium enhancement (LGE) images were used to calculate infarct size (IS).
3 secondary outcomes
Myocardial T1 Values and Extracellular Volume (ECV)
Time frame: At baseline (within 1 week of enrollment)
Myocardial T2 values
Time frame: At baseline (within 1 week of enrollment)
Myocardial Strain Analysis
Time frame: At baseline (within 1 week of enrollment)
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 19 Aug 2025.
- Individual participant dataSharing planned: No
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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 Cardiac Magnetic Resonance Imaging and Acute Myocardial Infarction (AMI), run by The Affiliated Hospital of Qingdao University 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 1 inclusion and 7 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 19 Aug 2025. 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 Pei Nie, MD (0532-82911500, niepei@qdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The myocardial uptake of 18F-Pentixafor was quantified using SUVmax and SUVmean values derived from PET imaging. (time frame: At baseline (within 1 week of enrollment)). The study lists 3 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 19 Aug 2025.