NCT04789564

Brief Summary

This study aim to investigate the predictive value of CMR parameters: infarct size (IS), intramyocardial hemorrhage, microvascular obstruction, area at risk and CMR derived strain parameters with the Major Adverse Cardiovascular Events (MACEs) and myocardial remodeling afterinfarction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

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

January 1, 2014

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 11, 2022

Status Verified

March 1, 2021

Enrollment Period

7 years

First QC Date

March 5, 2021

Last Update Submit

April 3, 2022

Conditions

Cardiovascular Diseases

Keywords

Intramyocardial Hemorrhage(IMH)Microvascular Obstruction(MVO)Area at Risk(AAR)CMR Related StrainST-segment elevation myocardial

Outcome Measures

Primary Outcomes (1)

  • MACEs

    MACEs concluding All-cause mortality, stroke, repeat revascularization, rehospitalization for acute heart failure, nonfatal myocardial infarction

    follow up in five years

Secondary Outcomes (2)

  • Left ventricular remodeling

    6 month after PCI

  • Contrast-induced acute kidney injury

    48 to 72 hours after PCI

Interventions

cardiovascular magnetic resonance (CMR)DIAGNOSTIC_TEST

Testing CMR on patients of 7 days and 6 months after myocardial infarction

Eligibility Criteria

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

Investigators will enroll 500 patients with STEMI after PCI who were admitted to the Chinese PLA General Hospital and other eight hospitals across China between January 2016 and January 2019. CMR was performed at 7 days and 6 months after primary PCI to assess the final infarction size, microvascular obstruction (MVO), area at risk (AAR) and related strain parameters. All patients will be followed up by 5 years after addimission index.

You may qualify if:

  • Age 18-80 years.
  • clinically diagnosed ST-segment elevation myocardial infarction.
  • Intended to undergo emergency PCI.
  • Voluntary enrollment and signed informed consent form.

You may not qualify if:

  • undergoing revascularization (PCI or coronary artery bypass grafting (CABG)) within 6 months;
  • Pregnant and breastfeeding women;
  • Contraindications of CMR: implanted cardiac defibrillator (ICD), claustrophobia, allergy to gadolinium
  • Liver or kidney failure;
  • Malignant tumor;
  • Unconscious at present;
  • systolic blood pressure (SBP) less than 80 mmHg;
  • Patients with bundle branch or fascicular block, insufficient ECG data.
  • Patients with other significant abnormal signs, laboratory tests and clinical disease are unsuitable for participation in the study accessed by clinicians.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (9)

  • Korosoglou G, Giusca S, Montenbruck M, Patel AR, Lapinskas T, Gotze C, Zieschang V, Al-Tabatabaee S, Pieske B, Florian A, Erley J, Katus HA, Kelle S, Steen H. Fast Strain-Encoded Cardiac Magnetic Resonance for Diagnostic Classification and Risk Stratification of Heart Failure Patients. JACC Cardiovasc Imaging. 2021 Jun;14(6):1177-1188. doi: 10.1016/j.jcmg.2020.10.024. Epub 2021 Jan 13.

    PMID: 33454266BACKGROUND

  • Amier RP, Tijssen RYG, Teunissen PFA, Fernandez-Jimenez R, Pizarro G, Garcia-Lunar I, Bastante T, van de Ven PM, Beek AM, Smulders MW, Bekkers SCAM, van Royen N, Ibanez B, Nijveldt R. Predictors of Intramyocardial Hemorrhage After Reperfused ST-Segment Elevation Myocardial Infarction. J Am Heart Assoc. 2017 Aug 15;6(8):e005651. doi: 10.1161/JAHA.117.005651.

    PMID: 28862937BACKGROUND

  • Kidambi A, Mather AN, Motwani M, Swoboda P, Uddin A, Greenwood JP, Plein S. The effect of microvascular obstruction and intramyocardial hemorrhage on contractile recovery in reperfused myocardial infarction: insights from cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2013 Jun 27;15(1):58. doi: 10.1186/1532-429X-15-58.

    PMID: 23806080BACKGROUND

  • Durante A, Laricchia A, Benedetti G, Esposito A, Margonato A, Rimoldi O, De Cobelli F, Colombo A, Camici PG. Identification of High-Risk Patients After ST-Segment-Elevation Myocardial Infarction: Comparison Between Angiographic and Magnetic Resonance Parameters. Circ Cardiovasc Imaging. 2017 Jun;10(6):e005841. doi: 10.1161/CIRCIMAGING.116.005841.

    PMID: 28592591BACKGROUND

  • Liang K, Nakou E, Del Buono MG, Montone RA, D'Amario D, Bucciarelli-Ducci C. The Role of Cardiac Magnetic Resonance in Myocardial Infarction and Non-obstructive Coronary Arteries. Front Cardiovasc Med. 2022 Jan 17;8:821067. doi: 10.3389/fcvm.2021.821067. eCollection 2021.

    PMID: 35111833BACKGROUND

  • Jensch PJ, Stiermaier T, Reinstadler SJ, Feistritzer HJ, Desch S, Fuernau G, de Waha-Thiele S, Thiele H, Eitel I. Prognostic relevance of peri-infarct zone measured by cardiovascular magnetic resonance in patients with ST-segment elevation myocardial infarction. Int J Cardiol. 2022 Jan 15;347:83-88. doi: 10.1016/j.ijcard.2021.11.017. Epub 2021 Nov 10.

    PMID: 34767896BACKGROUND

  • Scarsini R, Shanmuganathan M, De Maria GL, Borlotti A, Kotronias RA, Burrage MK, Terentes-Printzios D, Langrish J, Lucking A, Fahrni G, Cuculi F, Ribichini F, Choudhury RP, Kharbanda R, Ferreira VM, Channon KM, Banning AP; OxAMI Study Investigators. Coronary Microvascular Dysfunction Assessed by Pressure Wire and CMR After STEMI Predicts Long-Term Outcomes. JACC Cardiovasc Imaging. 2021 Oct;14(10):1948-1959. doi: 10.1016/j.jcmg.2021.02.023. Epub 2021 Apr 14.

    PMID: 33865789BACKGROUND

  • Hamirani YS, Wong A, Kramer CM, Salerno M. Effect of microvascular obstruction and intramyocardial hemorrhage by CMR on LV remodeling and outcomes after myocardial infarction: a systematic review and meta-analysis. JACC Cardiovasc Imaging. 2014 Sep;7(9):940-52. doi: 10.1016/j.jcmg.2014.06.012.

    PMID: 25212800BACKGROUND

  • Ganame J, Messalli G, Dymarkowski S, Rademakers FE, Desmet W, Van de Werf F, Bogaert J. Impact of myocardial haemorrhage on left ventricular function and remodelling in patients with reperfused acute myocardial infarction. Eur Heart J. 2009 Jun;30(12):1440-9. doi: 10.1093/eurheartj/ehp093. Epub 2009 Apr 3.

    PMID: 19346229BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 9, 2021

Study Start

January 1, 2014

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

April 11, 2022

Record last verified: 2021-03

Locations

CN(1)