NCT03768453

Brief Summary

The purpose of this registry is to depict the myocardial tissue characteristics in STEMI patients by CMR and other cardiac imaging modalities and to assess the prognostic value of imaging-derived indices. Information will be collected prospectively in about 1000 STEMI patients in 10 sites. Subjects will be followed for up to 5 years.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

May 8, 2012

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2019

Enrollment Period

8.2 years

First QC Date

December 3, 2018

Last Update Submit

June 19, 2020

Conditions

ST-segment Elevation Myocardial Infarction (STEMI)

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events

    MACE

    1 year

Eligibility Criteria

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

STEMI patients undergo CMR examination are eligible for this registry.

You may qualify if:

  • STEMI patients who have had CMR imaging performed and have provided written consent.
  • Patents older than 18 years old with myocardial infarction diagnosed by:
  • typical ischemic symptom,
  • New ischaemic ECG changes;: ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads ;
  • elevated cardiac troponin value with at least one value above 99th percentile upper reference limit(UPL);
  • confirmed by coronary angiography (CAG) or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischaemic aetiology.
  • Patients who have had CMR imaging performed and have agreed to comply with the follow up requirements.

You may not qualify if:

  • Patient who is unable to comply with the follow-up schedule.
  • Patient who has any medical conditions that in the opinion of the investigators will not be appropriate to participate in the study.
  • Patient has a life expectancy of less than 6 months due to any condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Related Publications (4)

  • Dong JX, Wei L, Jin LX, He J, Zhao CX, Ding S, Kong LC, Yang F, An DA, Wu CW, Chen BH, Wang HW, Yang YN, Ge H, Pu J. MR Uniformity Ratio Estimates to Evaluate Ventricular Mechanical Dyssynchrony and Prognosis After ST-Segment Elevation Myocardial Infarction. J Magn Reson Imaging. 2024 May;59(5):1820-1831. doi: 10.1002/jmri.28998. Epub 2023 Oct 13.

    PMID: 37830268DERIVED

  • Lai W, Chen-Xu Z, Jian-Xun D, Jie H, Ling-Cong K, Dong-Ao-Lei A, Bing-Hua C, Song D, Zheng L, Fan Y, Hu-Wen W, Jian-Rong X, Heng G, Jun P. Prognostic implications of left ventricular torsion measured by feature-tracking cardiac magnetic resonance in patients with ST-elevation myocardial infarction. Eur Heart J Cardiovasc Imaging. 2023 May 31;24(6):785-795. doi: 10.1093/ehjci/jeac177.

    PMID: 36056877DERIVED

  • Zhao Y, Lu X, Wan F, Gao L, Lin N, He J, Wei L, Dong J, Qin Z, Zhong F, Qiao Z, Wang W, Ge H, Ding S, Yang Y, Xiu J, Shan P, Yan F, Zhao S, Ji Y, Pu J. Disruption of Circadian Rhythms by Shift Work Exacerbates Reperfusion Injury in Myocardial Infarction. J Am Coll Cardiol. 2022 May 31;79(21):2097-2115. doi: 10.1016/j.jacc.2022.03.370.

    PMID: 35618347DERIVED

  • Lai W, Jie H, Jian-Xun D, Ling-Cong K, Jun-Tong Z, Bo-Zhong S, Dong-Ao-Lei A, Bing-Hua C, Song D, Zheng L, Fan Y, Yi-Ning Y, Fu-Hua Y, Jian-Cheng X, Hu-Wen W, Jian-Rong X, Heng G, Jun P. Impact of Concomitant Impairments of the Left and Right Ventricular Myocardial Strain on the Prognoses of Patients With ST-Elevation Myocardial Infarction. Front Cardiovasc Med. 2021 May 31;8:659364. doi: 10.3389/fcvm.2021.659364. eCollection 2021.

    PMID: 34136542DERIVED

Biospecimen

Retention: NONE RETAINED

Routine blood test includes CBC, Liver\&Renal function, VBG, cardiac enzymes, glucose, serum lipid etc.

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Jun Pu

    Renji Hospital, School of Medicine, Shanghai Jiaotong University.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Pu

CONTACT

08602168383164pujun310@hotmail.com

Heng Ge

CONTACT

08602168383164dr.geheng@foxmail.com

Study Design

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

Study Record Dates

First Submitted

December 3, 2018

First Posted

December 7, 2018

Study Start

May 8, 2012

Primary Completion

July 8, 2020

Study Completion

December 1, 2020

Last Updated

June 23, 2020

Record last verified: 2019-06

Locations

CN(1)