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AtherosclerosisCASABLANCANCT00842868

The CASABLANCA Study: Catheter Sampled Blood Archive in Cardiovascular Diseases

An observational study of Atherosclerosis and Contrast Induced Nephropathy, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
How many people
1,298 participants
Where
1 siteUnited States
Study dates
Sep 2008to Mar 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • evaluation for possible or confirmed coronary artery disease with or without intervention
  • evaluation of cerebrovascular and/or peripheral artery disease with or without intervention

Who cannot join

  • Inability or unwillingness to participate
  • Procedures without angiographic procedures

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: The CASABLANCA Study: Catheter Sampled Blood Archive in Cardiovascular Diseases. An Observational Biomarker Study

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.

Read the 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.

Keywords
atherosclerosis, contrast induced nephropathy, renal impairment, catheterization
Medical subject headings
Atherosclerosis, Renal Insufficiency

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. major cardiovascular event

    Measured: 1 year follow up

Secondary outcomes (1)

  1. renal dysfunction

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2009 (estimated)
  2. Study startSep 2008
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,298 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00842868
Sponsor's protocol ID
2008P001076
Acronym
CASABLANCA
Status last verified
Sep 2016
First submitted
10 Feb 2009
Last updated
19 Sep 2016
Results posted
No
Data monitoring committee
No

Publications

  • Bellomo TR, Liu Y, Gilliland TC, Miksenas H, Haidermota S, Wong M, Hu X, Cristino JR, Browne A, Plutzky J, Tsimikas S, Januzzi JL Jr, Natarajan P. Associations between lipoprotein(a), oxidized phospholipids, and extracoronary vascular disease. J Lipid Res. 2024 Jul;65(7):100585. doi: 10.1016/j.jlr.2024.100585. Epub 2024 Jun 26.

    PubMed 38942114

  • Januzzi JL Jr, van Kimmenade RRJ, Liu Y, Hu X, Browne A, Plutzky J, Tsimikas S, Blankstein R, Natarajan P. Lipoprotein(a), Oxidized Phospholipids, and Progression to Symptomatic Heart Failure: The CASABLANCA Study. J Am Heart Assoc. 2024 Jun 18;13(12):e034774. doi: 10.1161/JAHA.124.034774. Epub 2024 Jun 11.

    PubMed 38860394

  • Adusumalli S, Mohebi R, McCarthy CP, Megaret CA, Rhyne RF, Jaffer FA, Januzzi JL. Multiple Biomarkers to Predict Major Adverse Cardiovascular Events in Patients With Coronary Chronic Total Occlusions. medRxiv [Preprint]. 2023 Jul 23:2023.07.19.23292911. doi: 10.1101/2023.07.19.23292911.

    PubMed 37503157

  • Gilliland TC, Liu Y, Mohebi R, Miksenas H, Haidermota S, Wong M, Hu X, Cristino JR, Browne A, Plutzky J, Tsimikas S, Januzzi JL Jr, Natarajan P. Lipoprotein(a), Oxidized Phospholipids, and Coronary Artery Disease Severity and Outcomes. J Am Coll Cardiol. 2023 May 9;81(18):1780-1792. doi: 10.1016/j.jacc.2023.02.050.

    PubMed 37137588

  • Mohebi R, Murphy S, Jackson L, McCarthy C, Abboud A, Murtagh G, Gawel S, Miksenas H, Gaggin H, Januzzi JL Jr. Biomarker prognostication across Universal Definition of Heart Failure stages. ESC Heart Fail. 2022 Dec;9(6):3876-3887. doi: 10.1002/ehf2.14071. Epub 2022 Aug 8.

    PubMed 35942508

  • 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.

    PubMed 35574956

  • 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.

    PubMed 35361478

  • 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.

    PubMed 31217993

  • 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.

    PubMed 31047001

  • 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.

    PubMed 30487984

  • 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.

    PubMed 29519811

  • 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.

    PubMed 29424480

  • 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.

    PubMed 28487034

  • 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.

    PubMed 28254177

  • 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.

    PubMed 27881568

Questions about this trial

What is this clinical trial studying?

An observational study of Atherosclerosis and Contrast Induced Nephropathy, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

major cardiovascular event (time frame: 1 year follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00842868, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2016.

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