Predictive Value of Cardiovascular Magnetic Resonance Related Parameters in STEMI Patients After Primary PCI for Adverse Left Ventricular Remodeling and Major Adverse Cardiovascular Events

NCT ID: NCT04789564

Last Updated: 2022-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Investigators will enroll 500 patients with STEMI after PCI who were admitted to the Chinese PLA General Hospital and other eight hospitals across China: Wuhan Asia Heart Hospital; the First People's Hospital of Yunlin; Chaoyang Hospital, Capital Medical University; Hainan Hospital of PLA General Hospital; the Second Affiliated Hospital of Nanchang University; the Second Hospital of Hebei Medical University; Guizhou Provincial People's Hospital; Affiliated Hospital of Zunyi Medical College between January 2014 and December 2019. CMR was performed at 7 days and 6 months after primary PCI to assess the final infarction size(IS), microvascular obstruction (MVO), intramyocardial hemorrhage(IMH), area at risk (AAR) and related strain parameters. All patients will be followed up by 5 years after adimission. Cardiovascular events concluded stroke, repeat revascularization, rehospitalization for acute heart failure, nonfatal myocardial infarction, and all cause death. All adverse clinical events as well as study end points were monitored and adjudicated by the independent event committee.

Conditions

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Cardiovascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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cardiovascular magnetic resonance (CMR)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qian geng

OTHER

Sponsor Role lead

Responsible Party

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Qian geng

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 33454266 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28862937 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23806080 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28592591 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35111833 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34767896 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33865789 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25212800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19346229 (View on PubMed)

Other Identifiers

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qgeng-2021-2-16

Identifier Type: -

Identifier Source: org_study_id

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