Predictive Value of Osteopontin for Contrast Nephropathy

Contrast-induced Nephropathy Clinical Trial

Official title:

Early Detection of Contrast Induced Nephropathy After Coronary Angiography : Predictive Value of Osteopontin

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05547581
• Other study ID #: CIN
• Status: Not yet recruiting
• Start date: December 7, 2022
• Est. completion date: December 8, 2024

Study information

• Verified date: September 2022
• Source: Assiut University
• Contact: Noura G. Nasr, Master
• Phone: 01096137766
• Email: noura.victory[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 155
• Est. completion date: December 8, 2024
• Est. primary completion date: November 5, 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contrast-induced Nephropathy
• Kidney Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Noura gamal

References & Publications (7)

Ibrahim NE, McCarthy CP, Shrestha S, Lyass A, Li Y, Gaggin HK, Simon ML, Massaro JM, D'Agostino RB Sr, Garasic JM, van Kimmenade RR, Januzzi JL Jr. Blood kidney injury molecule-1 predicts short and longer term kidney outcomes in patients undergoing diagnostic coronary and/or peripheral angiography-Results from the Catheter Sampled Blood Archive in Cardiovascular Diseases (CASABLANCA) study. Am Heart J. 2019 Mar;209:36-46. doi: 10.1016/j.ahj.2018.12.001. Epub 2018 Dec 7. — View Citation

McCullough PA. Contrast-induced acute kidney injury. J Am Coll Cardiol. 2008 Apr 15;51(15):1419-28. doi: 10.1016/j.jacc.2007.12.035. Review. Erratum in: J Am Coll Cardiol.2008 Jun 3;51(22): 2197. — View 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. — View Citation

Mehran R, Owen R, Chiarito M, Baber U, Sartori S, Cao D, Nicolas J, Pivato CA, Nardin M, Krishnan P, Kini A, Sharma S, Pocock S, Dangas G. A contemporary simple risk score for prediction of contrast-associated acute kidney injury after percutaneous coronary intervention: derivation and validation from an observational registry. Lancet. 2021 Nov 27;398(10315):1974-1983. doi: 10.1016/S0140-6736(21)02326-6. Epub 2021 Nov 15. — View 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, Rimmelé 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. Erratum in: JAMA Netw Open. 2020 Nov 2;3(11):e2029182. — View Citation

PubMed

Pucelikova T, Dangas G, Mehran R. Contrast-induced nephropathy. Catheter Cardiovasc Interv. 2008 Jan 1;71(1):62-72. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early detection of patients at risk of (CA-AKI) before angiographic procedures	Early prediction of CIN for early prevention and proper management	Baseline