- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00842868
The CASABLANCA Study: Catheter Sampled Blood Archive in Cardiovascular Diseases (CASABLANCA)
The CASABLANCA Study: Catheter Sampled Blood Archive in Cardiovascular Diseases. An Observational Biomarker Study
Descripción general del estudio
Estado
Descripción detallada
The purpose of this research is to determine the relationship between (novel) cardiac and renal biomarkers before and after angiography. Clearly, having data immediately forewarning the clinician that cardiomyocyte injury has occurred, or that impending renal failure is ahead would allow for therapeutic intervention to reduce the likelihood for severe complications, and would ultimately pave the way for opportunities to derive methods to better prevent these complications. With the rapid evolution of organ-specific markers of injury comes an opportunity to explore new venues for their application.
With respect to myocardial injury, a new highly sensitive troponin molecule testing assays have recently been validated which enables to detect extremely small concentrations of troponin released in the circulation. With these assays, it may be possible to detect possible troponin release as early as minutes after injury has occurred.
Accordingly, as a primary goal of the CASABLANCA study, we will examine the release of high sensitivity troponin assays during catheterization and correlate with clinical and standard biochemical measures in order to see if a gradient of change during catheterization would be associated with subsequent recognition of peri-procedural myocardial infarction; it is the expectation that ultra high-sensitivity troponin methods will allow for nearly immediate recognition of complications following heart catheterization, when compared to the standard, non-high sensitivity methods currently in use.
With regards to peri-procedural renal injury, at present, several serum markers are being studied as potential markers or predictors in contrast induced nephropathy (CIN): Neutrophil gelatinase-associated lipocalin (NGAL) is highly accumulated in the kidney cortical tubules and leaks into the circulation after nephrotoxic and ischemic injuries. Up-regulation of the neutrophil adhesion receptor CD11b has also been associated with acute renal injury after cardiac surgery, while carbamylated hemoglobin performed quite well in differentiating acute kidney injury from elevated creatinine due to chronic kidney disease. Finally, Cystatin-C has shown to have a good accuracy for the early diagnosis of acute kidney injury before the clinical diagnosis as well.
In addition, blood will be stored for future testing of novel and experimental biomarkers in 'bench-to-bedside' collaborations, as a final yet crucial step in translational research.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- evaluation for possible or confirmed coronary artery disease with or without intervention
- evaluation of cerebrovascular and/or peripheral artery disease with or without intervention
Exclusion Criteria:
- Inability or unwillingness to participate
- Procedures without angiographic procedures
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
major cardiovascular event
Periodo de tiempo: 1 year follow up
|
1 year follow up
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
renal dysfunction
Periodo de tiempo: 1 year
|
1 year
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Mohebi R, van Kimmenade R, McCarthy C, Gaggin H, Mehran R, Dangas G, Januzzi JL Jr. A Biomarker-Enhanced Model for Prediction of Acute Kidney Injury and Cardiovascular Risk Following Angiographic Procedures: CASABLANCA AKI Prediction Substudy. J Am Heart Assoc. 2022 May 17;11(10):e025729. doi: 10.1161/JAHA.122.025729. Epub 2022 May 16.
- Mohebi R, Jackson L, McCarthy CP, Murtagh G, Murphy SP, Abboud A, Miksenas H, Gaggin HK, Januzzi JL Jr. Relation of High-Sensitivity Cardiac Troponin I and Obstructive Coronary Artery Disease in Patients Without Acute Myocardial Infarction. Am J Cardiol. 2022 Jun 15;173:16-24. doi: 10.1016/j.amjcard.2022.03.001. Epub 2022 Mar 28.
- McCarthy CP, Shrestha S, Ibrahim N, van Kimmenade RRJ, Gaggin HK, Mukai R, Magaret C, Barnes G, Rhyne R, Garasic JM, Januzzi JL. Performance of a clinical/proteomic panel to predict obstructive peripheral artery disease in patients with and without diabetes mellitus. Open Heart. 2019 May 13;6(1):e000955. doi: 10.1136/openhrt-2018-000955. eCollection 2019.
- Natarajan P, Collier TS, Jin Z, Lyass A, Li Y, Ibrahim NE, Mukai R, McCarthy CP, Massaro JM, D'Agostino RB Sr, Gaggin HK, Bystrom C, Penn MS, Januzzi JL Jr. Association of an HDL Apolipoproteomic Score With Coronary Atherosclerosis and Cardiovascular Death. J Am Coll Cardiol. 2019 May 7;73(17):2135-2145. doi: 10.1016/j.jacc.2019.01.073.
- Elmariah S, McCarthy C, Ibrahim N, Furman D, Mukai R, Magaret C, Rhyne R, Barnes G, van Kimmenade RRJ, Januzzi JL Jr. Multiple biomarker panel to screen for severe aortic stenosis: results from the CASABLANCA study. Open Heart. 2018 Nov 1;5(2):e000916. doi: 10.1136/openhrt-2018-000916. eCollection 2018.
- McCarthy CP, Ibrahim NE, Lyass A, Li Y, Gaggin HK, Simon ML, Mukai R, Gandhi P, Kelly N, Motiwala SR, van Kimmenade RRJ, Massaro JM, D'Agostino RB Sr, Januzzi JL Jr. Single-Molecule Counting of High-Sensitivity Troponin I in Patients Referred for Diagnostic Angiography: Results From the CASABLANCA (Catheter Sampled Blood Archive in Cardiovascular Diseases) Study. J Am Heart Assoc. 2018 Mar 8;7(6):e007975. doi: 10.1161/JAHA.117.007975.
- Ibrahim NE, Lyass A, Gaggin HK, Liu Y, van Kimmenade RRJ, Motiwala SR, Kelly NP, Gandhi PU, Simon ML, Belcher AM, Harisiades JE, Massaro JM, D'Agostino RB, Januzzi JL Jr. Predicting new-onset HF in patients undergoing coronary or peripheral angiography: results from the Catheter Sampled Blood Archive in Cardiovascular Diseases (CASABLANCA) study. ESC Heart Fail. 2018 Jun;5(3):240-248. doi: 10.1002/ehf2.12268. Epub 2018 Feb 9.
- McCarthy CP, van Kimmenade RRJ, Gaggin HK, Simon ML, Ibrahim NE, Gandhi P, Kelly N, Motiwala SR, Belcher AM, Harisiades J, Magaret CA, Rhyne RF, Januzzi JL Jr. Usefulness of Multiple Biomarkers for Predicting Incident Major Adverse Cardiac Events in Patients Who Underwent Diagnostic Coronary Angiography (from the Catheter Sampled Blood Archive in Cardiovascular Diseases [CASABLANCA] Study). Am J Cardiol. 2017 Jul 1;120(1):25-32. doi: 10.1016/j.amjcard.2017.03.265. Epub 2017 Apr 12.
- Ibrahim NE, Januzzi JL Jr, Magaret CA, Gaggin HK, Rhyne RF, Gandhi PU, Kelly N, Simon ML, Motiwala SR, Belcher AM, van Kimmenade RRJ. A Clinical and Biomarker Scoring System to Predict the Presence of Obstructive Coronary Artery Disease. J Am Coll Cardiol. 2017 Mar 7;69(9):1147-1156. doi: 10.1016/j.jacc.2016.12.021.
- Gaggin HK, Liu Y, Lyass A, van Kimmenade RR, Motiwala SR, Kelly NP, Mallick A, Gandhi PU, Ibrahim NE, Simon ML, Bhardwaj A, Belcher AM, Harisiades JE, Massaro JM, D'Agostino RB Sr, Januzzi JL Jr. Incident Type 2 Myocardial Infarction in a Cohort of Patients Undergoing Coronary or Peripheral Arterial Angiography. Circulation. 2017 Jan 10;135(2):116-127. doi: 10.1161/CIRCULATIONAHA.116.023052. Epub 2016 Nov 21.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2008P001076
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .