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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04481126
Other study ID # APHP201021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date December 2022

Study information

Verified date September 2021
Source Assistance Publique - Hôpitaux de Paris
Contact Paul GABARRE, MD
Phone +33 (0)1 49 09 56 45
Email paul.gabarre@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 168
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
France Nephrology department, Ambroise Paré hospital, APHP Boulogne-Billancourt

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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