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NCT Number: NCT07130409

Multimodal Imaging Assessment After Revascularization in Patients With Acute Myocardial Infarction

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.

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Key information

Conditions

Cardiac Magnetic Resonance Imaging Acute Myocardial Infarction (AMI) PET / MR

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Location status: Recruiting

Location contact

Pei Nie

CONTACT

[email protected]

0532-82911500

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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)

  2. Left ventricular ejection fraction (LVEF) assessed by cardiac MRI to evaluate left ventricular function

    Time frame: At baseline (within 1 week of enrollment)

  3. Infarct Characterization

    Time frame: At baseline (within 1 week of enrollment)

    Late gadolinium enhancement (LGE) images were used to calculate infarct size (IS).

Secondary outcomes

  1. Myocardial T1 Values and Extracellular Volume (ECV)

    Time frame: At baseline (within 1 week of enrollment)

    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).

  2. Myocardial T2 values

    Time frame: At baseline (within 1 week of enrollment)

    Myocardial T2 values were quantified using T2 mapping images to assess myocardial edema.

  3. Myocardial Strain Analysis

    Time frame: At baseline (within 1 week of enrollment)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pei Nie, MD

CONTACT

[email protected]

0532-82911500

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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