Clinical Risk Score Predicting the Cardiac Rupture in Patients With ST-elevation Myocardial Infarction

NCT ID: NCT02484326

Last Updated: 2015-06-29

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

3779 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-01-31

Brief Summary

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The purpose of this study is to validate a practical risk score to predict the mechanical complication of ST-elevation myocardial infarction (STEMI).

Detailed Description

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STEMI patients chewed 300 mg aspirin and 600 mg clopidogrel in the emergency department, followed by oral 100 mg aspirin and 75mg clopidogrel daily for at least 12 months. STEMI patients received low molecular weight heparin (LMWH), β-blockers, and angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) according to the STEMI guideline, unless there were contraindications to these drugs. Peripheral blood samples were collected from patients within 2 hours of admission for blood routines and blood biochemistry examinations. White blood cell counts and level of hemoglobin were assessed with automated cell counters via standard techniques. The investigators followed up patients in validation group for three month to observe the cardiac rupture events and other adverse cardiac events .

Conditions

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Cardiac Rupture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Grouping by different risk stratification

A simple risk score system based on 7 baseline clinical variables divided patients into four groups

Intervention Type OTHER

Other Intervention Names

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Risk stratification

Eligibility Criteria

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Inclusion Criteria

ST-elevation myocardial infarction: concurrence of symptoms (chest pain or symptoms compatible with acute heart failure or unexplained syncope) and electrocardiogram findings (new onset left bundle branch block or ST-segment elevation≥1 mm in ≥2 inferior leads or ≥2 mm in ≥2 precordial leads)

Exclusion Criteria

cancer mental illness
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qian geng

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Pouleur AC, Barkoudah E, Uno H, Skali H, Finn PV, Zelenkofske SL, Belenkov YN, Mareev V, Velazquez EJ, Rouleau JL, Maggioni AP, Kober L, Califf RM, McMurray JJ, Pfeffer MA, Solomon SD; VALIANT Investigators. Pathogenesis of sudden unexpected death in a clinical trial of patients with myocardial infarction and left ventricular dysfunction, heart failure, or both. Circulation. 2010 Aug 10;122(6):597-602. doi: 10.1161/CIRCULATIONAHA.110.940619. Epub 2010 Jul 26.

Reference Type RESULT
PMID: 20660803 (View on PubMed)

French JK, Hellkamp AS, Armstrong PW, Cohen E, Kleiman NS, O'Connor CM, Holmes DR, Hochman JS, Granger CB, Mahaffey KW. Mechanical complications after percutaneous coronary intervention in ST-elevation myocardial infarction (from APEX-AMI). Am J Cardiol. 2010 Jan 1;105(1):59-63. doi: 10.1016/j.amjcard.2009.08.653.

Reference Type RESULT
PMID: 20102891 (View on PubMed)

Figueras J, Barrabes JA, Serra V, Cortadellas J, Lidon RM, Carrizo A, Garcia-Dorado D. Hospital outcome of moderate to severe pericardial effusion complicating ST-elevation acute myocardial infarction. Circulation. 2010 Nov 9;122(19):1902-9. doi: 10.1161/CIRCULATIONAHA.109.934968. Epub 2010 Oct 25.

Reference Type RESULT
PMID: 20975001 (View on PubMed)

Lopez-Sendon J, Gurfinkel EP, Lopez de Sa E, Agnelli G, Gore JM, Steg PG, Eagle KA, Cantador JR, Fitzgerald G, Granger CB; Global Registry of Acute Coronary Events (GRACE) Investigators. Factors related to heart rupture in acute coronary syndromes in the Global Registry of Acute Coronary Events. Eur Heart J. 2010 Jun;31(12):1449-56. doi: 10.1093/eurheartj/ehq061. Epub 2010 Mar 15.

Reference Type RESULT
PMID: 20231153 (View on PubMed)

Jones BM, Kapadia SR, Smedira NG, Robich M, Tuzcu EM, Menon V, Krishnaswamy A. Ventricular septal rupture complicating acute myocardial infarction: a contemporary review. Eur Heart J. 2014 Aug 14;35(31):2060-8. doi: 10.1093/eurheartj/ehu248. Epub 2014 Jun 26.

Reference Type RESULT
PMID: 24970335 (View on PubMed)

Qian G, Liu HB, Wang JW, Wu C, Chen YD. Risk of cardiac rupture after acute myocardial infarction is related to a risk of hemorrhage. J Zhejiang Univ Sci B. 2013 Aug;14(8):736-42. doi: 10.1631/jzus.B1200306.

Reference Type RESULT
PMID: 23897793 (View on PubMed)

Roberts WC, Burks KH, Ko JM, Filardo G, Guileyardo JM. Commonalities of cardiac rupture (left ventricular free wall or ventricular septum or papillary muscle) during acute myocardial infarction secondary to atherosclerotic coronary artery disease. Am J Cardiol. 2015 Jan 1;115(1):125-40. doi: 10.1016/j.amjcard.2014.10.004. Epub 2014 Oct 13.

Reference Type RESULT
PMID: 25456862 (View on PubMed)

Qian G, Jin RJ, Fu ZH, Yang YQ, Su HL, Dong W, Guo J, Jing J, Guo YL, Chen YD. Development and validation of clinical risk score to predict the cardiac rupture in patients with STEMI. Am J Emerg Med. 2017 Apr;35(4):589-593. doi: 10.1016/j.ajem.2016.12.033. Epub 2016 Dec 15.

Reference Type DERIVED
PMID: 28132793 (View on PubMed)

Other Identifiers

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14FCJJ01

Identifier Type: -

Identifier Source: org_study_id

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