NCT02484326

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,779

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Typical duration 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, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
Last Updated

June 29, 2015

Status Verified

May 1, 2015

Enrollment Period

3 years

First QC Date

June 22, 2015

Last Update Submit

June 24, 2015

Conditions

Cardiac Rupture

Keywords

ST-elevation myocardial infarctionCardiac ruptureRisk assessment

Outcome Measures

Primary Outcomes (1)

  • Incidence of cardiac rupture

    Pericardial tamponade or electromechanical dissociation accompanied with massive pericardial effusion is the indicator of cardiac rupture

    3 month

Interventions

Grouping by different risk stratificationOTHER

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

Also known as: Risk stratification

Eligibility Criteria

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

ST-elevation myocardial infarction patients who were admitted from January 2012 to January 2013

You may qualify if:

  • 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)

You may not qualify if:

  • cancer mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (8)

  • 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.

    PMID: 20660803RESULT

  • 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.

    PMID: 20102891RESULT

  • 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.

    PMID: 20975001RESULT

  • 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.

    PMID: 20231153RESULT

  • 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.

    PMID: 24970335RESULT

  • 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.

    PMID: 23897793RESULT

  • 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.

    PMID: 25456862RESULT

  • 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.

    PMID: 28132793DERIVED

MeSH Terms

Conditions

Heart RuptureST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMyocardial InfarctionMyocardial IschemiaVascular 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

June 22, 2015

First Posted

June 29, 2015

Study Start

January 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

June 29, 2015

Record last verified: 2015-05

Locations

CN(1)