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NCT02484326 Clinical Trial

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

Cardiac Rupture Clinical Trial

Official title:
Development and Validation of a Clinical Risk Score Predicting the Cardiac Rupture in Patients With ST-elevation Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02484326
Other study ID # 14FCJJ01
Secondary ID
Status Completed
Phase N/A
First received June 22, 2015
Last updated June 24, 2015
Start date January 2012
Est. completion date January 2015

Study information
Verified date May 2015
Source Chinese PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority China: National Health and Family Planning Commission
Study type Observational

Clinical Trial Summary

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

Description:

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 .

Recruitment information / eligibility
Status Completed
Enrollment 3779
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Grouping by different risk stratification
A simple risk score system based on 7 baseline clinical variables divided patients into four groups

Locations
Country Name City State
China Chinese People's Liberation Army General Hospital Peking Beijing

Sponsors (1)
Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Figueras J, Barrabés JA, Serra V, Cortadellas J, Lidón 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/ — View Citation

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. — View Citation

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 — View Citation

López-Sendón 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 — View Citation

Pouleur AC, Barkoudah E, Uno H, Skali H, Finn PV, Zelenkofske SL, Belenkov YN, Mareev V, Velazquez EJ, Rouleau JL, Maggioni AP, Køber L, Califf RM, McMurray JJ, Pfeffer MA, Solomon SD; VALIANT Investigators. Pathogenesis of sudden unexpected death in a cl — View Citation

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. — View Citation

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 Ca — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of cardiac rupture Pericardial tamponade or electromechanical dissociation accompanied with massive pericardial effusion is the indicator of cardiac rupture 3 month Yes