Clinical trial NCT05547581: Predictive Value of Osteopontin for Contrast Nephropathy
Official title: Early Detection of Contrast Induced Nephropathy After Coronary Angiography : Predictive Value of Osteopontin
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Contrast-induced Nephropathy
Keywords: CIN
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sample size 155 at effect size 0.2 power 80 and alfa error 0.05

Brief summary: Early detection of contrast induced nephropathy by using osteopontin as an early marker for prediction

Detailed description: People who undergo coronary angiography are at risk of contrast-associated acute kidney injury (CA-AKI) .

The prevention therapy is the main approach to address CA-AKI, minimizing the volume of contrast media and intravenous hydration before and after the procedure which may not be appropriate for those with heart failure .

Given limited treatment options once CA-AKI develops and an unfavourable associated prognosis, early identification of those at risk of CA-AKI is crucial.

Also, there is studies was linking CA-AKI with a higher mortality rate and adverse future cardiovascular events, and risk for future CA-AKI events .

Mehran and colleagues described CA-AKI risk score predicting both CA-AKI and cardiovascular events after angiographic procedures.

however, studies have also investigated the role of different biomarkers in prediction of AKI like osteopontin, in 2020, a consensus statement was released regarding how best to incorporate kidney biomarkers into clinical practice.

Osteopontin is an extracellular structural protein synthesized by various cell types like osteoblasts, smooth muscle. and found in the loop of Henle and distal nephrons in normal kidneys. Recent studies have found that osteopontin has a critical role in tubulogenesis, cell apoptosis, promotion of cell regeneration. Lorenzen and colleagues found that critically ill patients with AKI have higher osteopontin concentrations than critically ill patients without AKI.

Few studies have investigated the role of osteopontin in the detection of AKI.

Eligibility criteria: Inclusion Criteria:

- patients undergoing coronary with or without intervention between 2022and 2024 were prospectively enrolled at the study.

Patients were referred for angiography for various acute and nonacute indications, including acute coronary syndromes, heart failure, abnormal stress tests, stable chest pain, claudication, and routine preoperative evaluation.

Patient with CKD stage 1 or 2 only

Exclusion Criteria:

* Pt has history of contrast induced nephropathy before. Patient known to have Chronic kidney disease stage 3A upto 5D Pt has contraindication for coronary angiograghy.

Primary outcomes:
measure: early detection of patients at risk of (CA-AKI) before angiographic procedures
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mohamed Sobh
role: STUDY_DIRECTOR
References:
citation: Mehran R, Aymong ED, Nikolsky E, Lasic Z, Iakovou I, Fahy M, Mintz GS, Lansky AJ, Moses JW, Stone GW, Leon MB, Dangas G. A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation. J Am Coll Cardiol. 2004 Oct 6;44(7):1393-9. doi: 10.1016/j.jacc.2004.06.068.
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citation: Ostermann M, Zarbock A, Goldstein S, Kashani K, Macedo E, Murugan R, Bell M, Forni L, Guzzi L, Joannidis M, Kane-Gill SL, Legrand M, Mehta R, Murray PT, Pickkers P, Plebani M, Prowle J, Ricci Z, Rimmele T, Rosner M, Shaw AD, Kellum JA, Ronco C. Recommendations on Acute Kidney Injury Biomarkers From the Acute Disease Quality Initiative Consensus Conference: A Consensus Statement. JAMA Netw Open. 2020 Oct 1;3(10):e2019209. doi: 10.1001/jamanetworkopen.2020.19209.
citation: PubMed