Clinical trial NCT03918824: Influence of Iodinated Contrast Volume Injected During Coronarography on Contrast Nephropathy.
Official title: Retrospective Analysis of the Influence of Iodinated Contrast Volume Injected During Coronarography on Contrast Nephropathy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephropathy
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients who have undergone percutaneous coronary intervention with contrast medium Xenetic (Lobitridol ®) in the CHU Brugmann Hospital coronary angiography unit since 2013.

Brief summary: Coronary heart disease remains one of the main causes of death in the world. One of the treatments for coronary heart disease is percutaneous coronary intervention (PCI). This requires the arterial administration of iodinated contrast medium (ICP) to visualize the state of the coronary arteries and possibly apply the treatment.

For the vast majority of the population, exposure to ICP is perfectly well tolerated. Nevertheless, some complications can occur including a nephropathy induced by the injection of a contrast product (NIC). NIC is the third cause of an acquired acute renal failure within the hospital.It significantly increases morbidity and mortality and prolongs the hospital stay.

Of all the procedures requiring ICP administration, PCI is associated with the highest rate of NIC.This evidence is explained by the fact that patients benefiting from such exploration have a higher risk profile in terms of cardiovascular comorbidities and associated pathologies.Age, preexisting alteration of renal function, diabetes mellitus, polypharmacy, congestive heart failure, type and volume of iodinated contrast medium are the main risk factors for developing NIC.

Nowadays, the use of PCI in the assessment of coronary heart disease in patients with these risk factors is becoming more frequent. This is linked to the aging of the population and the increasing incidence of cardiovascular diseases.

ICP-induced nephrotoxicity results from two main phenomena: the renal medullary hypoxia caused by the vasoconstriction of peritubular capillaries and a direct cytotoxicity towards tubular epithelial cells.These intra-renal mechanisms lead to an acute renal function impairment.NIC is defined as an increase of serum creatinemia ≥ 0.5 mg / dL (or a 25% increase) from the baseline in the 48-72h following PC injection with no other obvious etiology. It reaches its peak between the 3rd and 5th day with a resolution in 10 to 21 days.

The prevention of NIC based primarily on the identification of patients at risk and the use of pharmacological means (as hydration protocol). In contrast, there is little data on the relationship between NIC and the PCI volume used. To the investigator's knowledge, the threshold of toxic volume is not well defined. Taking into account these elements, the investigators propose to study the relation between the volume of iodinated contrast product injected during an ICP and the occurrence of a NIC according to the criteria mentioned above.


Eligibility criteria: Inclusion Criteria:

* All adult patients who have undergone percutaneous coronary intervention with contrast medium Xenetic (Lobitridol ®) in the CHU Brugmann Hospital coronary angiography unit since 2013
* Access to extensive demographic, clinical and biological data

Exclusion Criteria:

None

Primary outcomes:
measure: incidence of nephropathies induced by the injection of iodinate contrast medium
timeFrame: 7 years
measure: Volume of iodinated contrast medium injected
timeFrame: 1 day
measure: Body mass
timeFrame: 1 day
measure: Urea concentration
timeFrame: 10 days after PCI
measure: Creatinin rate
timeFrame: 10 days after PCI
measure: Glomerular filtration rate
timeFrame: 10 days after PCI
Secondary outcomes:
measure: Existence of risk factors (yes/no)
timeFrame: 7 years
measure: Urea concentration
timeFrame: Baseline (day of percutaneous coronary intervention (PCI))
measure: Urea concentration
timeFrame: 24 hours after of PCI
measure: Urea concentration
timeFrame: 48 hours after PCI
measure: Urea concentration
timeFrame: 72 hours after PCI
measure: Urea concentration
timeFrame: 21 days after PCI
measure: Urea concentration
timeFrame: 1 year after PCI
measure: Creatinin rate
timeFrame: Baseline (day of percutaneous coronary intervention (PCI))
measure: Creatinin rate
timeFrame: 24 hours after of PCI
measure: Creatinin rate
timeFrame: 48 hours after PCI
measure: Creatinin rate
timeFrame: 72 hours after PCI
measure: Creatinin rate
timeFrame: 21 days after PCI
measure: Creatinin rate
timeFrame: 1 year after PCI
measure: Glomerular filtration rate
timeFrame: Baseline (day of percutaneous coronary intervention (PCI))
measure: Glomerular filtration rate
timeFrame: 24 hours after of PCI
measure: Glomerular filtration rate
timeFrame: 48 hours after PCI
measure: Glomerular filtration rate
timeFrame: 72 hours after PCI
measure: Glomerular filtration rate
timeFrame: 21 days after PCI
measure: Glomerular filtration rate
timeFrame: 1 year after PCI
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Sarah Bensliman, MD
role: PRINCIPAL_INVESTIGATOR
References: