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The CASABLANCA Study: Catheter Sampled Blood Archive in Cardiovascular Diseases (CASABLANCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00842868
Recruitment Status : Completed
First Posted : February 12, 2009
Last Update Posted : September 19, 2016
Information provided by (Responsible Party):
James L. Januzzi, Massachusetts General Hospital

Brief 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.

Condition or disease
Atherosclerosis Contrast Induced Nephropathy Renal Impairment

Detailed 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.

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Study Type : Observational
Actual Enrollment : 1298 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The CASABLANCA Study: Catheter Sampled Blood Archive in Cardiovascular Diseases. An Observational Biomarker Study
Study Start Date : September 2008
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Primary Outcome Measures :
  1. major cardiovascular event [ Time Frame: 1 year follow up ]

Secondary Outcome Measures :
  1. renal dysfunction [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
serum and plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
1250 patients undergoing angiography as clinical standard (diagnostic or therapeutic) care;

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00842868

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: James L Januzzi, MD Massachusetts General Hospital
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: James L. Januzzi, Dr., Massachusetts General Hospital Identifier: NCT00842868    
Other Study ID Numbers: 2008P001076
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: September 2016
Keywords provided by James L. Januzzi, Massachusetts General Hospital:
contrast induced nephropathy
renal impairment
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Urologic Diseases