CRP KIN: Kinetics of C-Reactive Protein During the Management of Acute Coronary Syndrome Treated by Transluminal Angioplasty

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT05233176

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome

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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Kinetics of C-Reactive Protein During the Overall Management of Acute Coronary Syndrome Treated by Transluminal Angioplasty

Actual Study Start Date :

Mar 2, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Outcome Measures

Primary Outcome Measures

Plasma CRP kinetic [Pre-angioplasty, hour 6, hour 12, hour 24, hour 48 and daily post angioplasty until day 7 then weekly untill day 30]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiology department, Ambroise Paré hospital, APHP	Boulogne-Billancourt		France	92100
2	Intensive care unit, Ambroise Paré hospital, APHP	Boulogne-Billancourt		France	92100

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

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