NCT07130409

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Aug 2025Dec 2026

First Submitted

Initial submission to the registry

July 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

July 30, 2025

Last Update Submit

August 15, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • The myocardial uptake of 18F-Pentixafor was quantified using SUVmax and SUVmean values derived from PET imaging.

    At baseline (within 1 week of enrollment)

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

    At baseline (within 1 week of enrollment)

  • Infarct Characterization

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

    At baseline (within 1 week of enrollment)

Secondary Outcomes (3)

  • Myocardial T1 Values and Extracellular Volume (ECV)

    At baseline (within 1 week of enrollment)

  • Myocardial T2 values

    At baseline (within 1 week of enrollment)

  • Myocardial Strain Analysis

    At baseline (within 1 week of enrollment)

Study Arms (1)

clinically diagnosed with first-episode AMI and undergoing interventional therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

clinically diagnosed with first-episode AMI and undergoing interventional therapy

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 19, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations