- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02484326
Clinical Risk Score Predicting the Cardiac Rupture in Patients With ST-elevation Myocardial Infarction
June 24, 2015 updated by: Qian geng, Chinese PLA General Hospital
Development and Validation of a Clinical Risk Score Predicting the Cardiac Rupture in Patients With ST-elevation Myocardial Infarction
The purpose of this study is to validate a practical risk score to predict the mechanical complication of ST-elevation myocardial infarction (STEMI).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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 .
Study Type
Observational
Enrollment (Actual)
3779
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Peking, Beijing, China, 100853
- Chinese People's Liberation Army General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
ST-elevation myocardial infarction patients who were admitted from January 2012 to January 2013
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of cardiac rupture
Time Frame: 3 month
|
Pericardial tamponade or electromechanical dissociation accompanied with massive pericardial effusion is the indicator of cardiac rupture
|
3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
June 22, 2015
First Submitted That Met QC Criteria
June 24, 2015
First Posted (Estimate)
June 29, 2015
Study Record Updates
Last Update Posted (Estimate)
June 29, 2015
Last Update Submitted That Met QC Criteria
June 24, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14FCJJ01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiac Rupture
-
Maastricht University Medical CenterRecruitingPost-Infarction Heart Rupture | Gene PolymorphismItaly
-
National Police HospitalCompletedRupture of Anterior Cruciate Ligament | Rupture of Posterior Cruciate LigamentKorea, Republic of
-
GCS Ramsay Santé pour l'Enseignement et la RechercheNot yet recruiting
-
Bispebjerg HospitalCompleted
-
GCS Ramsay Santé pour l'Enseignement et la RechercheRecruiting
-
The Methodist Hospital Research InstituteRecruiting
-
University Hospital Inselspital, BerneRecruitingFlexor Tendon RuptureSwitzerland
-
Peking University Third HospitalRecruitingRegeneration | Meniscus RuptureChina
-
Peking University Third HospitalRecruitingAchilles Tendon RuptureChina
-
Fonds de Dotation pour la Recherche Clinique en...Recruiting
Clinical Trials on Grouping by different risk stratification
-
University of AlbertaCompletedMyocardial Injury | Death, Cardiac | Myocardial Infarction PostoperativeCanada
-
University of Texas Southwestern Medical CenterActive, not recruitingColoRectal CancerUnited States
-
University Health Network, TorontoRecruiting
-
Charite University, Berlin, GermanyUnknown
-
Institute for Clinical Evaluative SciencesCompleted
-
Fox Chase Cancer CenterActive, not recruitingSurgery | Tumors | Primary Neoplasm | Secondary NeoplasmUnited States
-
Jubilee Mission Medical College and Research InstituteCompleted
-
National Research Center for Preventive MedicineCompletedNon ST Segment Elevation Acute Coronary SyndromeRussian Federation
-
Zhang longjiang,MDRecruitingAdherence, Medication | Primary Prevention | Cardiovascular Risk Factors | StatinChina
-
Haukeland University HospitalHelse Stavanger HF; Helse Fonna; Helse Forde; Haraldsplass Deaconess HospitalCompleted