- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05233176
Kinetics of C-Reactive Protein During the Management of Acute Coronary Syndrome Treated by Transluminal Angioplasty (CRP KIN)
Kinetics of C-Reactive Protein During the Overall Management of Acute Coronary Syndrome Treated by Transluminal Angioplasty
Study Overview
Status
Conditions
Detailed Description
During the management of acute coronary syndrome with ST segment elevation (ACS-ST+), an ischemia-reperfusion syndrome is observed in connection with primary coronary occlusion (ischemia) and percutaneous angioplasty during the therapeutic coronary reperfusion.
This ischemia-reperfusion syndrome results biologically in an inflammatory syndrome evaluated in particular by the assay of C-reactive protein (CRP). CRP is a marker of inflammation used in routine practice. Previous studies have reported the prognostic value of CRP at the 48th hour of hospital treatment for ST+ ACS. If the value of CRP is correlated with the risk of mortality and heart failure, the fact remains that no study has, to date, studied its kinetics during the overall management (pre and intra-hospital) of ACS ST+. This is all the more important since the previous therapies taken by the patient (statins for example) and/or those administered during treatment (colchicine, ticagrelor, anti-GPIIbIIIa are capable of modifying the pre-hospital value of the CRP.
In this study, the kinetics of plasma CRP measured during the first medical contact (emergency, cardiology or resuscitation), then, in the catheterization room before the angioplasty procedure, then in the catheterization room, after the angioplasty, then at the 6th hour (H6), at the 12th hour (H12), at the 24th hour (H24), at the 48th hour (H48) and once a week until the 7th day then once a week until discharge hospitalization with a maximum of 30 days of follow-up, as part of the usual follow-up of patients with ST+ ACS requiring emergency transluminal angioplasty.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Boulogne-Billancourt, France, 92100
- Intensive care unit, Ambroise Paré hospital, APHP
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Boulogne-Billancourt, France, 92100
- Cardiology department, Ambroise Paré hospital, APHP
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age over 18 years old;
- ST+ ACS requiring emergency transluminal angioplasty;
- Affiliation to a social security scheme or beneficiary.
Exclusion Criteria:
- ST+ ACS not requiring emergency transluminal angioplasty;
- Pregnancy;
- Under guardianship or curatorship;
- Foreign patient under french AME scheme.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Plasma CRP kinetic
Time Frame: Pre-angioplasty, hour 6, hour 12, hour 24, hour 48 and daily post angioplasty until day 7 then weekly untill day 30
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Blood sampling: Pre-angioplasty, on H6, H12, H24, H48 and once a day post angioplasty until the 7th day; then once a week until discharge from hospital with a maximum of 30 days
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Pre-angioplasty, hour 6, hour 12, hour 24, hour 48 and daily post angioplasty until day 7 then weekly untill day 30
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Collaborators and Investigators
Investigators
- Principal Investigator: Romain Jouffroy, MD, PhD, Intensive Care Unit - Ambroise Paré Hospital - APHP
- Study Director: Marie Hauguel-Moreau, MD, Cardiology department, Ambroise Paré hospital, APHP
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP 211274
- 2021-A02081-40 (Other Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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