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

Acute Coronary Syndrome Clinical Trial

— CRP KIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05233176
• Other study ID #: APHP 211274
• Secondary ID: 2021-A02081-40
• Status: Recruiting
• Start date: March 2, 2022
• Est. completion date: April 2024

Study information

• Verified date: March 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Romain Jouffroy, MD, PhD
• Phone: + 33 (0)1 49095601
• Email: romain.jouffroy[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
France	Cardiology department, Ambroise Paré hospital, APHP	Boulogne-Billancourt
France	Intensive care unit, Ambroise Paré hospital, APHP	Boulogne-Billancourt

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma CRP kinetic	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	Pre-angioplasty, hour 6, hour 12, hour 24, hour 48 and daily post angioplasty until day 7 then weekly untill day 30