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

September 27, 2021 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

168

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Boulogne-Billancourt, France, 92100
        • Recruiting
        • Nephrology department, Ambroise Paré hospital, APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of acute renal failure
Time Frame: at baselin and at 48 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Paul GABARRE, MD, Nephrology department, Ambroise Paré hospital, APHP
  • Study Director: Eve Vilaine, MD, Nephrology department, Ambroise Paré hospital, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

July 17, 2020

First Submitted That Met QC Criteria

July 17, 2020

First Posted (Actual)

July 22, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP201021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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