Acute Renal Insufficiency (ARI) Rate and Predictive Score of ARI in Hospitalized Patients for Acute Coronary Syndrome With ST-segment Elevation Needing Urgent Coronarography

NCT04481126 | Unknown

• 1 other identifier: APHP201021
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study aims to evaluate frequence of acute renal insufficiency in patients with ST-segment elevation who need urgent coronary angiography in Ambroise Paré hospital. The secondary objectives are:

• identify factors of risks associated with the occurrence of acute renal insufficiency after coronarography.
• establish a preprocedure score, predicting of acute renal insufficiency after urgent coronary angiography in patients with ST+ acute coronary syndrome.

Conditions

Acute Renal Insufficiency; Acute Coronary Syndrome

Keywords

Acute Renal Insufficiency; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• incidence of acute renal failure

  Acute renal failure is defined as an increase in plasma creatinine of at least 26.5µmol/l within 48 hours, or an increase in plasma creatinine of at least 1.5 times plasma creatinine within 48hours of hospitalisation

  at baselin and at 48 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient hospitalized in Ambroise Paré hospital in the period between Jan 2017 to Jul 2019, who have been an urgent coronarography, and have a renal insufficiency needing dialysis.

You may qualify if:

• patient aged ≥ 18 years;
• evocative symptoms of myocardiac ischemia: typical chest pain; ST-segment elevation and 1 mm in two consecutive peripheral leads and 2 mm in two consecutive precordial derivations, or appearance of a bloc of left branch of novo;
• need urgent coronarography;
• Covered by french social security scheme included CMU.

You may not qualify if:

• dialysed patient for chronic renal insufficiency;
• cardio-resporatory arrest;
• cardiogenic choc state;
• prior emergency passage to hospital;
• patient under tutor, gardianship;
• patient covered by french AME scheme;
• pregnant women or breastfeeding;
• all medical, psychological or social situation which should influents the compliance to protocol according to investigator;
• patient refusal.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Nephrology department, Ambroise Paré hospital, APHP

Boulogne-Billancourt, 92100, France

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Paul GABARRE, MD

  Nephrology department, Ambroise Paré hospital, APHP

  PRINCIPAL INVESTIGATOR

• Eve Vilaine, MD

  Nephrology department, Ambroise Paré hospital, APHP

  STUDY DIRECTOR

Central Study Contacts

Paul GABARRE, MD

CONTACT

+33 (0)1 49 09 56 45; paul.gabarre@aphp.fr

Eve Vilaine, MD

CONTACT

+33 (0)1 49 09 56 45; eve.vilaine@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 22, 2020
• Study Start: July 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)