Effects Contrast on Platelet Activity, Thrombosis and Fibrinolysis in Patients Undergoing Coronary Angiography

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Guerbet
Information provided by (Responsible Party):
Frederick Feit, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01848899
First received: April 23, 2013
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

The aim of this study is to determine how two different types of iodinated contrast media (CM) agents, low-osmolar ionic ioxaglate and iso-osmolar non-ionic iodixanol, affect specific markers of thrombogenesis and platelet function in patients undergoing coronary angiography, and if the use of bivalirudin, a direct thrombin inhibitor used during percutaneous coronary intervention (PCI), affects any contrast-related changes in thrombogenesis and platelet function.

Currently more than 1 million percutaneous coronary interventions (PCI) are performed in the United States annually. Despite the use of antiplatelet and anticoagulant pharmacotherapy, thrombotic complications of PCI continue to cause significant morbidity, especially in already high risk patients. In addition to adjunctive anti- thrombotic and anti-platelet therapy, the type of contrast agent used may also affect thrombus formation by directly affecting specific coagulation factors, fibrinolytic factors, and platelet degranulation, aggregation, or adhesion.

Optimizing thrombotic risk in patients requiring coronary angiography with or without intervention is paramount to patient care. This is especially true if a type of contrast agent is found to have a superior role in reducing factors known to increase peri-procedural thromboembolic events.


Condition Intervention Phase
Patients Referred for Coronary Angiography
Drug: Type of contrast administered during coronary angiography (ioxaglate or iodixanol)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: The Assesment of Thrombotic Markers Utilizing Ionic Versus Non-Ionic Contrast During Coronary Angiography and Intervention (AToMIC) Trial

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • thrombin generation test [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    change in thrombin generation test from baseline to after coronary angiography


Secondary Outcome Measures:
  • thrombin-antithrombin (TAT) complex [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • fibrinopeptide A [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • prothrombin fragment 1+2 [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • monocyte and leukocyte platelet aggregates [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • light transmission aggregometry [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: February 2013
Estimated Study Completion Date: June 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Randomized arm
The study will be a prospective, randomized study of patients (n=100) undergoing coronary angiography. Patients will be randomly assigned to either receive ioxaglate or iodixanol during coronary angiography. The primary outcome measure will be a change in thrombin generation test from baseline to after coronary angiography. Secondary outcomes will include a change in other markers of platelet activity and thrombogenesis between baseline and after coronary angiography. In addition, in patients undergoing PCI, differences in markers after the administration of bivalirudin and after PCI will be evaluated.
Drug: Type of contrast administered during coronary angiography (ioxaglate or iodixanol)
No Intervention: Registry cohort
In addition, we will have a registry for patients (n=30) requiring emergent cardiac catheterization for ST-segment elevation myocardial infarction (no randomization component; choice of contrast will be left up to operator preference). Blood samples will be obtained from arterial sheath at the beginning and at the end of the procedure (2 time points).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be more than 18 years of age
  • referred for coronary angiography and on dual anti-platelet therapy (aspirin and clopidogrel).

Exclusion Criteria:

  • on warfarin
  • on low molecular weight heparin within 12 hours of coronary angiography or unfractionated heparin with activated clotting time >150 at time of procedure -on cilostazol
  • on persantine
  • on non- steroidal anti-inflammatory medications (ibuprofen/motrin/advil, naproxen/aleve, indomethacin, sulindac, etodolac, diclofenac, celecoxib) within 72 hours of procedure
  • on prasugrel (not an exclusion criteria for ST-segment elevation myocardial infarction registry
  • undergoing coronary angiography via radial access
  • undergoing planned diagnostic coronary angiography only
  • unable to tolerate dual anti-platelet therapy
  • with known allergy to CM
  • received CM within 24 hours of coronary angiography
  • on dialysis
  • do not consent or are unable to give consent
  • are participating in another competing study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01848899

Locations
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Guerbet
Investigators
Principal Investigator: Fred Feit, MD New York University School of Medicine
Principal Investigator: Binita Shah, MD, MS New York University School of Medicine
  More Information

No publications provided

Responsible Party: Frederick Feit, Associate Professor of Medicine, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01848899     History of Changes
Other Study ID Numbers: S12-02409
Study First Received: April 23, 2013
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Coronary angiography
Percutaneous coronary intervention
Contrast media
Platelet activity
Thrombin generation
Fibrinolysis

Additional relevant MeSH terms:
Ioxaglic Acid
Iodixanol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014