|- candidate number||9083|
|- NTR Number||NTR2741|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-feb-2011|
|- Secondary IDs||NL29888.042.10 CCMO|
|- Public Title||Onderzoek naar optreden van hartfalen na een hartaanval.|
|- Scientific Title||Predictors Of heart failure after ST-elevation Myocardial Infarction: An observational study.|
|- hypothesis||The main aim of the current study is to identify novel pathophysiological pathways associated with the development of heart failure after an acute myocardial infarction.|
|- Healt Condition(s) or Problem(s) studied||Myocardial infarction , Biomarkers, Genetics, Heart failure|
|- Inclusion criteria||1. Patients admitted with an acute myocardial infarction and candidates for primary PCI. A diagnosis of acute myocardial infarction is defined by chest pain suggestive for myocardial ischemia for at least 30 minutes with a time from onset of symptoms of less than 24 hours before hospital admission and an ECG with ST segment elevation of more than 0.1mV in 2 or more leads;|
2. Minimum age 18 years;
3. Verbal followed by written informed consent.
|- Exclusion criteria||1. Presence of other serious medical conditions with a life expectancy of less than 6 months;|
2. Unwilling to sign informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-feb-2011|
|- planned closingdate||1-feb-2016|
|- Target number of participants||2400|
|- Primary outcome||Time till first hospitalization for heart failure or heart failure related mortality.|
|- Secondary outcome||1. Reinfarction;|
2. Stent thrombosis;
4. Cardiac mortality (including sudden cardiac arrest survivors);
5. All-cause mortality;
6. Combination of all endpoints.
|- Timepoints||Total follow-up duration is 3-5 years.|
|- Trial web site||www.post-mi.org|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. F.W. Asselbergs|
|- CONTACT for SCIENTIFIC QUERIES||Dr. F.W. Asselbergs|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale: |
Heart failure (HF) is a major medical problem of the Western world, carrying a high morbidity, mortality and economic burden. An ischemic etiology such as an acute myocardial infarction (MI) underlies the development of HF in 70% of all cases. A substantial part of the susceptibility to develop ischemic HF is thought to be largely genetically based. However, genetic variants causing HF have only been identified in some families suffering from non-ischemic HF.
The main aim of the current study is to identify novel pathophysiological pathways associated with the development of post-MI HF using genome-wide data and innovative bioinformatics approaches.
The study is a multi-center, prospective, longitudinal, observational study.
Patients admitted for treatment of a myocardial infarction are considered for inclusion.
Main study parameters/endpoints:
The primary outcome is the incidence of hospitalizations for heart failure. Secondary endpoints include reinfarction, stent thrombosis, arrhythmias, cardiac mortality, all-cause mortality and the combination of all these endpoints.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
This is an observational study. Participants will not be exposed to any risks associated with participation to the current study. Participants will not have any advantages or disadvantages by participating in the current study.
|- Main changes (audit trail)|
|- RECORD||8-feb-2011 - 19-feb-2011|