Ignite Creation Date:
2024-05-06 @ 1:55 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04163250
Status:
COMPLETED
Last Update Posted:
2021-08-17
First Post:
2019-11-10
Brief Title:
Use of Urinary Cell-Cycle Arrest Biomarkers in Contrast-Associated Nephropathy After Coronary Angiography
Sponsor:
Eva de Miguel Balsa
Organization:
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Study Overview
Official Title:
Prognostic Value of Urinary TIMP-2 IGFBP7 in Intra-Arterial Contrast-Associated Acute Kidney Injury
Status:
COMPLETED
Status Verified Date:
2021-08
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:
Radiological examinations that require the administration of iodinated contrasts IC for diagnostic and therapeutic purposes are essential in current clinical practice and their use in interventional procedures has been progressively increasing
IC can cause kidney damage so there is caution in their use in at-risk populations This fact may limit its diagnostic use with data on underutilization of interventional techniques in patients with renal insufficiency which worsen their prognosis
In addition once the use of IC contrasts is decided preventive measures such as hyperhydrationare used and can have potential side effects especially in patients at risk of heart failure acute coronary syndrome low left ventricular ejection fraction
New biomarkers of kidney damage have recently been developed based on the detection of molecules expressed by the kidney in situations of early damage The quantitative determination of cell cycle arrest proteins Tissue Inhibitor of metalloproteinase 2 TIMP2 and Insulin-Like Growth Factor Binding Protein -7 IGFBP7 can be predictive of the development of moderate to severe contrast-associated acute kidney injury
Urinary determination of TIMP-2 x IGFBP7 in patients with ACS acute coronary syndromes before cardiac catheterization would allow early identification of those patients vulnerable to IC-induced toxicity and adjustment of preventive measures
IC can cause kidney damage so there is caution in their use in at-risk populations This fact may limit its diagnostic use with data on underutilization of interventional techniques in patients with renal insufficiency which worsen their prognosis
In addition once the use of IC contrasts is decided preventive measures such as hyperhydrationare used and can have potential side effects especially in patients at risk of heart failure acute coronary syndrome low left ventricular ejection fraction
New biomarkers of kidney damage have recently been developed based on the detection of molecules expressed by the kidney in situations of early damage The quantitative determination of cell cycle arrest proteins Tissue Inhibitor of metalloproteinase 2 TIMP2 and Insulin-Like Growth Factor Binding Protein -7 IGFBP7 can be predictive of the development of moderate to severe contrast-associated acute kidney injury
Urinary determination of TIMP-2 x IGFBP7 in patients with ACS acute coronary syndromes before cardiac catheterization would allow early identification of those patients vulnerable to IC-induced toxicity and adjustment of preventive measures
Detailed Description:
Urinary determination of TIMP-2 x IGFBP7 in patients with ACS undergoing cardiac catheterization would allow early identification of those patients vulnerable to IC-induced toxicity and adjustment of both appropriate preventive measures
A prospective descriptive observational study will be carried out to determine sensitivity and specificity of the urinary determination of TIMP2-IGFBP7 and predictive values in the early diagnosis of contrast-associated acute kidney injury AKI in patients admitted to the Coronary Care Unit CCU in a spanish hospital
OBJECTIVES
PRIMARY OBJECTIVE To determine the operational characteristics sensitivity specificity of the TIMP2-IGFBP7 biomarker in routine clinical practice in the early diagnosis of contrast-induced AKI acute renal injury in patients admitted to the CCU exposed to iodinated contrasts The established renal failure is defined as KDIGO Kidney Disease Improving Global Outcomes stage 2 in the 24 to 72 hours after the administration of contrasts
SECONDARY OBJECTIVES
Evaluate these parameters according to the patients initial risk level
Estimated renal function upon admission
Initial severity estimated by GRACE score
Sex
Age
Contrast media type and volume
Patient weight
Dose of contrast
Diabetes
A single determination 10 ml of fresh urine should be collected in a sterile container and the laboratory should centrifuge them within the time of collection Neither the attending physicians nor the investigators will know the results and the treatment will not be influenced
The result is reported as a single value which is the concentration of TIMP-2 ng mL multiplied by the concentration of IGFBP7 ng mL divided by 1000 The result is reported without any unit or concentrations of individual biomarkers As previously reported a value of 03 identifies patients with a high probability of presenting a moderate to severe AKI acute kidney injury in 12 hours while a value of 03 identifies patients with a low risk of developing a moderate to serious AKI
An aliquot of urine will be stored at -80 C in the Clinical Analysis Department
A prospective descriptive observational study will be carried out to determine sensitivity and specificity of the urinary determination of TIMP2-IGFBP7 and predictive values in the early diagnosis of contrast-associated acute kidney injury AKI in patients admitted to the Coronary Care Unit CCU in a spanish hospital
OBJECTIVES
PRIMARY OBJECTIVE To determine the operational characteristics sensitivity specificity of the TIMP2-IGFBP7 biomarker in routine clinical practice in the early diagnosis of contrast-induced AKI acute renal injury in patients admitted to the CCU exposed to iodinated contrasts The established renal failure is defined as KDIGO Kidney Disease Improving Global Outcomes stage 2 in the 24 to 72 hours after the administration of contrasts
SECONDARY OBJECTIVES
Evaluate these parameters according to the patients initial risk level
Estimated renal function upon admission
Initial severity estimated by GRACE score
Sex
Age
Contrast media type and volume
Patient weight
Dose of contrast
Diabetes
A single determination 10 ml of fresh urine should be collected in a sterile container and the laboratory should centrifuge them within the time of collection Neither the attending physicians nor the investigators will know the results and the treatment will not be influenced
The result is reported as a single value which is the concentration of TIMP-2 ng mL multiplied by the concentration of IGFBP7 ng mL divided by 1000 The result is reported without any unit or concentrations of individual biomarkers As previously reported a value of 03 identifies patients with a high probability of presenting a moderate to severe AKI acute kidney injury in 12 hours while a value of 03 identifies patients with a low risk of developing a moderate to serious AKI
An aliquot of urine will be stored at -80 C in the Clinical Analysis Department
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