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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05547581
Other study ID # CIN
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
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