- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05547581
Predictive Value of Osteopontin for Contrast Nephropathy
Early Detection of Contrast Induced Nephropathy After Coronary Angiography : Predictive Value of Osteopontin
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Noura G. Nasr, Master
- Phone Number: 01096137766
- Email: noura.victory@gmail.com
Study Contact Backup
- Name: Nashwa M. Azoz, Doctora
- Phone Number: 01001543446
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
early detection of patients at risk of (CA-AKI) before angiographic procedures
Time Frame: Baseline
|
Early prediction of CIN for early prevention and proper management
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mohamed Sobh, Assiut University
Publications and helpful links
General Publications
- 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.
- 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. Erratum In: J Am Coll Cardiol.2008 Jun 3;51(22): 2197.
- Pucelikova T, Dangas G, Mehran R. Contrast-induced nephropathy. Catheter Cardiovasc Interv. 2008 Jan 1;71(1):62-72. doi: 10.1002/ccd.21207.
- 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.
- 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.
- 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. Erratum In: JAMA Netw Open. 2020 Nov 2;3(11):e2029182.
- PubMed
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Contrast-induced Nephropathy
-
Minia UniversityNot yet recruitingContrast-induced Nephropathy
-
Gaziosmanpasa Research and Education HospitalRecruitingContrast-induced Nephropathy | Contrast-Associated Acute Kidney InjuryTurkey (Türkiye)
-
Singapore General HospitalActive, not recruitingContrast-induced NephropathySingapore
-
Chinese PLA General HospitalUnknownContrast-induced NephropathyChina
-
Memorial University of NewfoundlandUniversity of AlbertaWithdrawnContrast Induced NephropathyCanada
-
Sun Yat-sen UniversityCompletedContrast Induced NephropathyChina
-
Isfahan University of Medical SciencesUnknownContrast-Induced NephropathyIran, Islamic Republic of
-
Osprey Medical, IncCompletedContrast Induced Nephropathy (CIN)United States, New Zealand, Australia
-
The Nazareth HospitalWestern Galilee Hospital-NahariyaUnknownContrast Media Induced NephropathyIsrael
-
Mt. Sinai Medical Center, MiamiFlorida Heart Research InstituteCompleted