NCT06669520

Brief Summary

This research will explore the association between blood serum renalase and microcirculation obstruction in patients with acute myocardial infarction (AMI) after primary percutaneous coronary intervention (PCI). The investigators aim to identify potential risk factors for microcirculation obstruction in AMI patients after PPCI.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

November 1, 2024

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

October 29, 2024

Last Update Submit

October 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Microvascular Obstruction Assessed by Contrast-Enhanced Magnetic Resonance Imaging 3-7 Days After Percutaneous Coronary Intervention.

    Microvascular obstruction (MVO) was qualitatively recognized as a subendocardial lack of enhancement at first-pass perfusion (FPP) sequences and as a hypointense region within the hyperintense infarcted area at early gadolinium enhancement (EGE) and late gadolinium enhancement (LGE) sequences.

    3-7 days after PPCI

Eligibility Criteria

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

The study population will include 200 patients diagnosed with acute myocardial infarction (AMI) who will undergo primary percutaneous coronary intervention (PCI) at the Third Xiangya Hospital of Central South University, from August 2024 to August 2025.

You may qualify if:

  • Age ≥ 18 years;
  • STEMI symptom onset time \< 12 hours;
  • STEMI symptom onset time 12-48 hours with persistent ischemic symptoms, hemodynamic instability, or life-threatening ventricular arrhythmias;
  • High-risk NSTEMI;
  • Emergency PCI;
  • Voluntary informed consent.

You may not qualify if:

  • Non-obstructive acute myocardial infarction;
  • Severe chronic kidney disease (defined as estimated glomerular filtration rate \< 20 mL/min per 1.73 m²);
  • Life expectancy \< 1 year;
  • Pregnant or planning to become pregnant;
  • Emergency PCI failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

RECRUITING

Related Publications (1)

  • Chen Y, Li R, Fu R, Zhao L, Sheng Z, Xu K, Liu J, Huang W, Wen J, Zeng L, Ou Z, Jiang Z, Liu Y, Wang Y, Jiang W, Li X. Association between periprocedural change in serum renalase and microvascular obstruction in patients with STEMI after primary percutaneous coronary intervention: protocol for the ReMVOS prospective cohort study. BMJ Open. 2025 Nov 28;15(11):e110045. doi: 10.1136/bmjopen-2025-110045.

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

October 29, 2024

First Posted

November 1, 2024

Study Start

August 1, 2024

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

November 1, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations