NCT06759532

Brief Summary

The aims of the study were to evaluate the predictive value of persistent microvascular obstruction (MVO) by cardiac magnetic resonance for main adverse cardiac events in ST-segment elevation myocardial infarction patients. MVO in the acute phase of myocardial infarction has been considered to be strong predictor of a poor prognosis. We plan to explore the relationship between persistent MVO and the long-term prognosis of patients with STEMI. We made hypothesis that patients with persistent MVO have a poor prognosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
344

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2017

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
Last Updated

January 6, 2025

Status Verified

December 1, 2024

Enrollment Period

7.3 years

First QC Date

December 30, 2024

Last Update Submit

December 30, 2024

Conditions

Keywords

Microvascular occlusion;ST-segment elevation myocardial infarctionPrognosis

Outcome Measures

Primary Outcomes (1)

  • Main aderverse cardiac events

    Composite endpoint of all-cause death, readmission due to heart failure, recurrent myocardial infarction, and unexpected vascularization.

    5 years after myocardiac infarction

Study Arms (3)

Without MVO group

STEMI patients without MVO both in the acutephase and chronic phase of myocardial inarction

with transient MVO group

STEMI patients with MVO only in the acutephase of myocardial inarction

with persietent MVO group

STEMI patients without MVO both in the acutephase and chronic phase of myocardial inarction

Eligibility Criteria

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

The patients in this study were diagnosis as STEMI, and were plan to undergo primary percutaneous coronary intervention and were plan to underwent cardiac magnetic resonance at 7 days and 6 months after primary percutaneous coronary intervention . The patients were divided into three groups according to the presence of absence of MVO at the first cardiac magnetic resonance and second cardiac magnetic resonance.

You may qualify if:

  • ST-segment elevation myocardial infarction undewent primary percutaneous coronary intervention

You may not qualify if:

  • contraindications for cardiac magnetic resonance
  • severe heart failure
  • previous myocardial infarction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA general hospital

Beijing, Beijing Municipality, 10086, China

Location

Related Publications (8)

  • Symons R, Pontone G, Schwitter J, Francone M, Iglesias JF, Barison A, Zalewski J, de Luca L, Degrauwe S, Claus P, Guglielmo M, Nessler J, Carbone I, Ferro G, Durak M, Magistrelli P, Lo Presti A, Aquaro GD, Eeckhout E, Roguelov C, Andreini D, Vogt P, Guaricci AI, Mushtaq S, Lorenzoni V, Muller O, Desmet W, Agati L, Janssens S, Bogaert J, Masci PG. Long-Term Incremental Prognostic Value of Cardiovascular Magnetic Resonance After ST-Segment Elevation Myocardial Infarction: A Study of the Collaborative Registry on CMR in STEMI. JACC Cardiovasc Imaging. 2018 Jun;11(6):813-825. doi: 10.1016/j.jcmg.2017.05.023. Epub 2017 Aug 16.

    PMID: 28823746BACKGROUND
  • Bodi V, Gavara J, Lopez-Lereu MP, Monmeneu JV, de Dios E, Perez-Sole N, Bonanad C, Marcos-Garces V, Canoves J, Minana G, Nunez J, Moratal D, Chorro FJ, Rodriguez-Palomares JF, Freixa A, Borras R, Ortiz-Perez JT, Rios-Navarro C. Impact of Persistent Microvascular Obstruction Late After STEMI on Adverse LV Remodeling: A CMR Study. JACC Cardiovasc Imaging. 2023 Jul;16(7):919-930. doi: 10.1016/j.jcmg.2023.01.021. Epub 2023 Apr 12.

    PMID: 37052556BACKGROUND
  • Lechner I, Reindl M, Stiermaier T, Tiller C, Holzknecht M, Oberhollenzer F, von der Emde S, Mayr A, Feistritzer HJ, Carberry J, Carrick D, Bauer A, Thiele H, Berry C, Eitel I, Metzler B, Reinstadler SJ. Clinical Outcomes Associated With Various Microvascular Injury Patterns Identified by CMR After STEMI. J Am Coll Cardiol. 2024 May 28;83(21):2052-2062. doi: 10.1016/j.jacc.2024.03.408.

    PMID: 38777509BACKGROUND
  • Orn S, Manhenke C, Greve OJ, Larsen AI, Bonarjee VV, Edvardsen T, Dickstein K. Microvascular obstruction is a major determinant of infarct healing and subsequent left ventricular remodelling following primary percutaneous coronary intervention. Eur Heart J. 2009 Aug;30(16):1978-85. doi: 10.1093/eurheartj/ehp219. Epub 2009 Jun 6.

    PMID: 19502624BACKGROUND
  • Bodi V, Sanchis J, Lopez-Lereu MP, Nunez J, Sanz R, Palau P, Gomez C, Moratal D, Chorro FJ, Llacer A. Microvascular perfusion 1 week and 6 months after myocardial infarction by first-pass perfusion cardiovascular magnetic resonance imaging. Heart. 2006 Dec;92(12):1801-7. doi: 10.1136/hrt.2005.077305. Epub 2006 Jun 27.

    PMID: 16803939BACKGROUND
  • Weir RA, Murphy CA, Petrie CJ, Martin TN, Balmain S, Clements S, Steedman T, Wagner GS, Dargie HJ, McMurray JJ. Microvascular obstruction remains a portent of adverse remodeling in optimally treated patients with left ventricular systolic dysfunction after acute myocardial infarction. Circ Cardiovasc Imaging. 2010 Jul;3(4):360-7. doi: 10.1161/CIRCIMAGING.109.897439. Epub 2010 Mar 26.

    PMID: 20348438BACKGROUND
  • van Kranenburg M, Magro M, Thiele H, de Waha S, Eitel I, Cochet A, Cottin Y, Atar D, Buser P, Wu E, Lee D, Bodi V, Klug G, Metzler B, Delewi R, Bernhardt P, Rottbauer W, Boersma E, Zijlstra F, van Geuns RJ. Prognostic value of microvascular obstruction and infarct size, as measured by CMR in STEMI patients. JACC Cardiovasc Imaging. 2014 Sep;7(9):930-9. doi: 10.1016/j.jcmg.2014.05.010.

    PMID: 25212799BACKGROUND
  • Rios-Navarro C, Marcos-Garces V, Bayes-Genis A, Husser O, Nunez J, Bodi V. Microvascular Obstruction in ST-Segment Elevation Myocardial Infarction: Looking Back to Move Forward. Focus on CMR. J Clin Med. 2019 Oct 28;8(11):1805. doi: 10.3390/jcm8111805.

    PMID: 31661823BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionMyocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 30, 2024

First Posted

January 6, 2025

Study Start

April 1, 2017

Primary Completion

July 20, 2024

Study Completion

October 20, 2024

Last Updated

January 6, 2025

Record last verified: 2024-12

Locations