Acute Renal InsufficiencyCOROAKINCT04481126
Acute Renal Insufficiency (ARI) Rate and Predictive Score of ARI in Hospitalized Patients for Acute Coronary Syndrome With ST-segment Elevation Needing Urgent Coronarography
An observational study of Acute Renal Insufficiency and Acute Coronary Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Insufficiency, Acute Coronary Syndrome
- How many people
- 168 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2020to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- pregnant women or breastfeeding;
- all medical, psychological or social situation which should influents the compliance to protocol according to investigator;
- patient refusal.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Nephrology department, Ambroise Paré hospital, APHP
Boulogne-Billancourt, 92100
About this study
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
- Medical subject headings
- Acute Kidney Injury, Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at baselin and at 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start1 Jul 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul GABARRE, MD, Principal investigator, Nephrology department, Ambroise Paré hospital, APHPEve Vilaine, MD, Study director, Nephrology department, Ambroise Paré hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481126
- Sponsor's protocol ID
- APHP201021
- Acronym
- COROAKI
- Status last verified
- Sep 2021
- First submitted
- 17 Jul 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Renal Insufficiency (ARI) Rate and Predictive Score of ARI in Hospitalized Patients for Acute Coronary Syndrome With ST-segment Elevation Needing Urgent Coronarography
- ClinicalTrials.gov ID
- NCT04481126
- Acronym / sponsor ID
- COROAKI / APHP201021
- Conditions
- Acute Renal Insufficiency, Acute Coronary Syndrome
- Keywords
- Acute Renal Insufficiency, Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- dialysed patient for chronic renal insufficiency;
- cardio-resporatory arrest;
- cardiogenic choc state;
- prior emergency passage to hospital;
- patient under tutor, gardianship;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul GABARRE, MD principal investigator
Nephrology department, Ambroise Paré hospital, APHP
Eve Vilaine, MD study director
Nephrology department, Ambroise Paré hospital, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Renal Insufficiency and Acute Coronary Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul GABARRE, MD (+33 (0)1 49 09 56 45, paul.gabarre@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of acute renal failure (time frame: at baselin and at 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.