Cardiac RuptureNCT02484326
Clinical Risk Score Predicting the Cardiac Rupture in Patients With ST-elevation Myocardial Infarction
An observational study of Cardiac Rupture, run by Chinese PLA General Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Rupture
- What is being tested?
- Grouping by different risk stratification
- How many people
- 3,779 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ST-elevation myocardial infarction patients who were admitted from January 2012 to January 2013
Who may be able to join
- 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)
Who cannot join
- cancer mental illness
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100853
About this study
Official title: 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).
Read the 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 .
- Conditions
- Cardiac Rupture
- Being tested
- Grouping by different risk stratification
- Keywords
- ST-elevation myocardial infarction, Cardiac rupture, Risk assessment
- Medical subject headings
- Heart Rupture, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grouping by different risk stratificationOther
Also called Risk stratification
A simple risk score system based on 7 baseline clinical variables divided patients into four groups
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cardiac rupture
Pericardial tamponade or electromechanical dissociation accompanied with massive pericardial effusion is the indicator of cardiac rupture
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startJan 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiac RuptureStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,779 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian geng, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484326
- Sponsor's protocol ID
- 14FCJJ01
- Status last verified
- May 2015
- First submitted
- 22 Jun 2015
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 20660803French 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.
PubMed 20102891Figueras 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.
PubMed 20975001Lopez-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.
PubMed 20231153Jones 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.
PubMed 24970335Qian 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.
PubMed 23897793Roberts 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.
PubMed 25456862Qian 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.
PubMed 28132793
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Clinical Risk Score Predicting the Cardiac Rupture in Patients With ST-elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02484326
- Acronym / sponsor ID
- 14FCJJ01
- Conditions
- Cardiac Rupture
- Keywords
- ST-elevation myocardial infarction, Cardiac rupture, Risk assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,779 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ST-elevation myocardial infarction patients who were admitted from January 2012 to January 2013
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- cancer mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grouping by different risk stratificationAlso: Risk stratificationA simple risk score system based on 7 baseline clinical variables divided patients into four groups | Other | – |
Primary outcome
Incidence of cardiac rupture
Time frame: 3 month
Pericardial tamponade or electromechanical dissociation accompanied with massive pericardial effusion is the indicator of cardiac rupture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
- Results publication: PubMed 20660803Pouleur 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.
- Results publication: PubMed 20102891French 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.
- Results publication: PubMed 20975001Figueras 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.
- Results publication: PubMed 20231153Lopez-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.
- Results publication: PubMed 24970335Jones 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.
- Results publication: PubMed 23897793Qian 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.
- Results publication: PubMed 25456862Roberts 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.
- Derived from this study: PubMed 28132793Qian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Rupture, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cardiac rupture (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02484326, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2015.