Effects Contrast on Platelet Activity, Thrombosis and Fibrinolysis in Patients Undergoing Coronary Angiography
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.
Patients Referred for Coronary Angiography
Drug: Type of contrast administered during coronary angiography (ioxaglate or iodixanol)
|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|
- thrombin generation test [ Time Frame: 1 hour ] [ Designated as safety issue: No ]change in thrombin generation test from baseline to after coronary angiography
- 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 ]
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||June 2014|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01848899
|United States, New York|
|New York University School of Medicine|
|New York, New York, United States, 10016|
|Principal Investigator:||Fred Feit, MD||New York University School of Medicine|
|Principal Investigator:||Binita Shah, MD, MS||New York University School of Medicine|