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Completed

NCT Number: NCT03918824

Influence of Iodinated Contrast Volume Injected During Coronarography on Contrast Nephropathy.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data extraction from medical files

Other

Data extraction from medical files

Primary outcomes

  1. incidence of nephropathies induced by the injection of iodinate contrast medium

    Time frame: 7 years

    incidence of nephropathy induced by injection of contrast medium

  2. Volume of iodinated contrast medium injected

    Time frame: 1 day

    Volume of iodinated contrast medium injected

  3. Body mass

    Time frame: 1 day

    Body mass

  4. Urea concentration

    Time frame: 10 days after PCI

    Urea concentration

  5. Creatinin rate

    Time frame: 10 days after PCI

    Creatinin rate

  6. Glomerular filtration rate

    Time frame: 10 days after PCI

    Glomerular filtration rate

Secondary outcomes

  1. Existence of risk factors (yes/no)

    Time frame: 7 years

    Existence of at least one of these risk factors: diabetes mellitus, abnormal blood pressure, abnormal kidney function, congestive heart failure.

  2. Urea concentration

    Time frame: Baseline (day of percutaneous coronary intervention (PCI))

    Urea concentration

  3. Urea concentration

    Time frame: 24 hours after of PCI

    Urea concentration

  4. Urea concentration

    Time frame: 48 hours after PCI

    Urea concentration

  5. Urea concentration

    Time frame: 72 hours after PCI

    Urea concentration

  6. Urea concentration

    Time frame: 21 days after PCI

    Urea concentration

  7. Urea concentration

    Time frame: 1 year after PCI

    Urea concentration

  8. Creatinin rate

    Time frame: Baseline (day of percutaneous coronary intervention (PCI))

    Creatinin rate

  9. Creatinin rate

    Time frame: 24 hours after of PCI

    Creatinin rate

  10. Creatinin rate

    Time frame: 48 hours after PCI

    Creatinin rate

  11. Creatinin rate

    Time frame: 72 hours after PCI

    Creatinin rate

  12. Creatinin rate

    Time frame: 21 days after PCI

    Creatinin rate

  13. Creatinin rate

    Time frame: 1 year after PCI

    Creatinin rate

  14. Glomerular filtration rate

    Time frame: Baseline (day of percutaneous coronary intervention (PCI))

    Glomerular filtration rate

  15. Glomerular filtration rate

    Time frame: 24 hours after of PCI

    Glomerular filtration rate

  16. Glomerular filtration rate

    Time frame: 48 hours after PCI

    Glomerular filtration rate

  17. Glomerular filtration rate

    Time frame: 72 hours after PCI

    Glomerular filtration rate

  18. Glomerular filtration rate

    Time frame: 21 days after PCI

    Glomerular filtration rate

  19. Glomerular filtration rate

    Time frame: 1 year after PCI

    Glomerular filtration rate

Sponsors and collaborators

Lead sponsor

Agnieszka Pozdzik

Other

Registry information

Official study title

Retrospective Analysis of the Influence of Iodinated Contrast Volume Injected During Coronarography on Contrast Nephropathy.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2019
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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