The CASABLANCA Study: Catheter Sampled Blood Archive in Cardiovascular Diseases

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
James L. Januzzi, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00842868
First received: February 10, 2009
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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
Atherosclerosis
Contrast Induced Nephropathy
Renal Impairment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The CASABLANCA Study: Catheter Sampled Blood Archive in Cardiovascular Diseases. An Observational Biomarker Study

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • major cardiovascular event [ Time Frame: 1 year follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • renal dysfunction [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum and plasma


Estimated Enrollment: 1250
Study Start Date: September 2008
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

1250 patients undergoing angiography as clinical standard (diagnostic or therapeutic) care;

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842868

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: James L Januzzi, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: James L. Januzzi, Dr., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00842868     History of Changes
Other Study ID Numbers: 2008P001076
Study First Received: February 10, 2009
Last Updated: April 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
atherosclerosis
contrast induced nephropathy
renal impairment
catheterization

Additional relevant MeSH terms:
Atherosclerosis
Cardiovascular Diseases
Kidney Diseases
Renal Insufficiency
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014