NCT00842868

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,298

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 19, 2016

Status Verified

September 1, 2016

Enrollment Period

6.5 years

First QC Date

February 10, 2009

Last Update Submit

September 16, 2016

Conditions

Keywords

atherosclerosiscontrast induced nephropathyrenal impairmentcatheterization

Outcome Measures

Primary Outcomes (1)

  • major cardiovascular event

    1 year follow up

Secondary Outcomes (1)

  • renal dysfunction

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Inability or unwillingness to participate
  • Procedures without angiographic procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (15)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma

MeSH Terms

Conditions

AtherosclerosisRenal Insufficiency

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • James L Januzzi, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 12, 2009

Study Start

September 1, 2008

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

September 19, 2016

Record last verified: 2016-09

Locations