Ignite Creation Date:
2024-05-06 @ 1:02 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03918824
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2019-03-26
Brief Title:
Influence of Iodinated Contrast Volume Injected During Coronarography on Contrast Nephropathy
Sponsor:
Agnieszka Pozdzik
Organization:
Brugmann University Hospital
Study Overview
Official Title:
Retrospective Analysis of the Influence of Iodinated Contrast Volume Injected During Coronarography on Contrast Nephropathy
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hospitalIt 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 NICThis evidence is explained by the fact that patients benefiting from such exploration have a higher risk profile in terms of cardiovascular comorbidities and associated pathologiesAge 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 cellsThese intra-renal mechanisms lead to an acute renal function impairmentNIC is defined as an increase of serum creatinemia 05 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 investigators 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
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 hospitalIt 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 NICThis evidence is explained by the fact that patients benefiting from such exploration have a higher risk profile in terms of cardiovascular comorbidities and associated pathologiesAge 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 cellsThese intra-renal mechanisms lead to an acute renal function impairmentNIC is defined as an increase of serum creatinemia 05 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 investigators 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None