Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278519
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-12-19
Brief Title:
CARdiAc Mri and BiOLogical samplEs at the Acute Phase of a Myocardial Infarction CARAMBOLE
Sponsor:
Poitiers University Hospital
Organization:
Poitiers University Hospital
Study Overview
Official Title:
Cardiac MRI and Biological Samples at the Acute Phase of a Myocardial Infarction
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARAMBOLE
Brief Summary:
ST-Segment Elevation Myocardial infarction STEMI corresponding to acute occlusion of cornary artery is the most severe ischemic myocardial disease and a leading cause of mortality of heart failure worldwide Although acute mortality from STEMI has decreased over the last decades the prognosis remains pejorative and difficult to anticipate The best management of STEMI patients depends of predictive factors of clinical prognosis and justifies an active research of these factors in particular the mechanisms leading to deleterious left ventricular remodeling myocardial inflammation reperfusion injury including the no-reflow phenomenon which is a major determinant of heart failure Cohorts of consecutive STEMI patients with a comprehensive assessment of clinical biological and imaging parameters are needed to offer the basis for new hypothese for research or interventions and to precisely evaluate the quality of care provided
The main objective of this study is to identify new markers clinical biological and imaging treatment response and prognosis after STEMI
Secondary objectives of the CARAMBOLE cohort are to establish a comprehensive clinical databse completed with biological samples and imaging data that can be used in the following areas
Descriptive epidemiology of STEMI and myocardial reperfusion
Evaluation of the clinical implications of the realization of a cardiac MRI at the acute phase of STEMI regarding no-reflow LVEF intra cardiac thrombi
Treatments observatory safety efficacy indication of treatments provided in real life compared to the treatments recommended adherence to treatments costs
Quality of life personal familial social and professional consequences of myocardial infarction
Research of new diagnostic and prognosis biomarkers
Research projects eg risk of developping cgnitive disorders in patients with STEMI as compared to the general population
Participants will undergo
a cardiac MRI at the acute phase of their STEMI 5 - 3 days then at 1 year follow-up
biological samples including blood urinary and feces samples at the acute phase of their STEMI from admission and up to 8 days then at 1 year follow-up
questionnaire assessment regarding their quality of life cognitive statusand socio-economic conditions at the acute phase and 1 year follow-up of their STEMI
The main objective of this study is to identify new markers clinical biological and imaging treatment response and prognosis after STEMI
Secondary objectives of the CARAMBOLE cohort are to establish a comprehensive clinical databse completed with biological samples and imaging data that can be used in the following areas
Descriptive epidemiology of STEMI and myocardial reperfusion
Evaluation of the clinical implications of the realization of a cardiac MRI at the acute phase of STEMI regarding no-reflow LVEF intra cardiac thrombi
Treatments observatory safety efficacy indication of treatments provided in real life compared to the treatments recommended adherence to treatments costs
Quality of life personal familial social and professional consequences of myocardial infarction
Research of new diagnostic and prognosis biomarkers
Research projects eg risk of developping cgnitive disorders in patients with STEMI as compared to the general population
Participants will undergo
a cardiac MRI at the acute phase of their STEMI 5 - 3 days then at 1 year follow-up
biological samples including blood urinary and feces samples at the acute phase of their STEMI from admission and up to 8 days then at 1 year follow-up
questionnaire assessment regarding their quality of life cognitive statusand socio-economic conditions at the acute phase and 1 year follow-up of their STEMI
Detailed Description:
Myocardial infarction is one of the leading causes of morbi-mortality causing 75 of cases of sudden death in adults over 35 years of age and more than half of chronic heart failure Despite the progress made based on French data from the CIRCUS study and the FAST-MI registry all-cause mortality at 1 year remained high at around 8 and the rate of occurrence of composite events death heart failure myocardial infarction revascularization stroke estimated around 25 ST-segment elevation myocardial infarction STEMI is the most severe form of ischemic myocardial disease The recommended treatment is the quickest possible unblocking of the coronary artery responsible for STEMI by coronary angioplasty treatment of choice if time limits are compatible or more rarely thrombolysis However this revascularization causes undesirable collateral effects with tissue edema intra-myocardial hemorrhages microvascular obstruction and local inflammation which contribute to significantly aggravate myocardial damage These reperfusion injuries increase the risk of Left Ventricular LV dysfunction Thus immediate mortality decreases but the incidence of heart failure following STEMI increases Several other parameters associated with a poor prognosis remain to this day incompletely understood and treated deleterious left ventricular remodeling LVR post-infarction inflammation no-reflow
Furthermore performing a systematic MRI at the acute phase of STEMI will allow to assess the real prevalence of intra LV thrombi and to treat them before hospital discharge Indeed the prevalence of intraLV thrombi is estimated around 20 but only 16 are diagnosed during the stay in the Cardiology Intensive Care Unit CICU low sensitivity of echocardiography lack of availability of cardiac MRI These patients must be treated with anticoagulants to limit the embolic phenomena of intra LV thrombi in particular strokes but most patients therefore do not benefit from this treatment when leaving the hospital since MRI is not performed in the acute phase in most centers due to lack of availability
The organization of prospective cohorts with well-documented biological and imaging collections in particular the systematic use of myocardial MRI and monitoring of events at 1 year will thus make it possible to better understand the complex pathophysiology of these deleterious phenomena their clinical consequences to propose research hypotheses and ultimately to developp innovative and personalized treatments
Furthermore performing a systematic MRI at the acute phase of STEMI will allow to assess the real prevalence of intra LV thrombi and to treat them before hospital discharge Indeed the prevalence of intraLV thrombi is estimated around 20 but only 16 are diagnosed during the stay in the Cardiology Intensive Care Unit CICU low sensitivity of echocardiography lack of availability of cardiac MRI These patients must be treated with anticoagulants to limit the embolic phenomena of intra LV thrombi in particular strokes but most patients therefore do not benefit from this treatment when leaving the hospital since MRI is not performed in the acute phase in most centers due to lack of availability
The organization of prospective cohorts with well-documented biological and imaging collections in particular the systematic use of myocardial MRI and monitoring of events at 1 year will thus make it possible to better understand the complex pathophysiology of these deleterious phenomena their clinical consequences to propose research hypotheses and ultimately to developp innovative and personalized treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None