Overview

This trial is active, not recruiting.

Conditions atherosclerosis, contrast induced nephropathy, renal impairment
Sponsor Massachusetts General Hospital
Start date September 2008
End date March 2015
Trial size 1250 participants
Trial identifier NCT00842868, 2008P001076

Summary

The purpose of this research is to determine the relationship between novel blood tests for heart function (including hormones and heart enzymes measured in the blood), and assess for kidney damage before and after angiography (cardiac catheterization). We hypothesize that these novel tests will enable us to predict possible complications of catheterization immediately after the procedure.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
major cardiovascular event
time frame: 1 year follow up

Secondary Outcomes

Measure
renal dysfunction
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The CASABLANCA Study: Catheter Sampled Blood Archive in Cardiovascular Diseases. An Observational Biomarker Study
Principal investigator James L Januzzi, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.