Clinical trial NCT05233176: Kinetics of C-Reactive Protein During the Management of Acute Coronary Syndrome Treated by Transluminal Angioplasty
Official title: Kinetics of C-Reactive Protein During the Overall Management of Acute Coronary Syndrome Treated by Transluminal Angioplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Keywords: acute coronary syndrome
C reactive protein
kinetic
adults
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients cared for ST+ ACS requiring emergency transluminal angioplasty.

Brief summary: The primary objective of the study focuses on the kinetics of plasma CRP measured during the overall management (before the angioplasty procedure until the discharge of hospitalization) of patients with ST+ ACS requiring emergency transluminal angioplasty.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Plasma CRP kinetic
timeFrame: Pre-angioplasty, hour 6, hour 12, hour 24, hour 48 and daily post angioplasty until day 7 then weekly untill day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Cardiology department, Ambroise Paré hospital, APHP
city: Boulogne-Billancourt
country: France
facility: Intensive care unit, Ambroise Paré hospital, APHP
Study officials:
affiliation: Intensive Care Unit - Ambroise Paré Hospital - APHP
name: Romain Jouffroy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiology department, Ambroise Paré hospital, APHP
name: Marie Hauguel-Moreau, MD
role: STUDY_DIRECTOR
References:
citation: Milwidsky A, Ziv-Baran T, Letourneau-Shesaf S, Keren G, Taieb P, Berliner S, Shacham Y. CRP velocity and short-term mortality in ST segment elevation myocardial infarction. Biomarkers. 2017 May-Jun;22(3-4):383-386. doi: 10.1080/1354750X.2017.1279218. Epub 2017 Jan 25.