Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT00266994
Eligibility Criteria:
Inclusion Criteria:
* Patients should be enrolled at the time of their FIRST thromboembolic event. Ideally, patients should be enrolled within three months of the diagnosis of an eligible event.
* Deep Venous, Arterial, or Intra-Cardiac Thrombosis
* Pulmonary Thromboembolism AND:
* Must have evidence of Venous Thrombosis on imaging studies -OR-
* Must have elevated Quantitative or Semi-Quantitative D-dimer level (as defined by local laboratory technology/normal ranges)
* Arterial Thromboembolism (with imaging evidence of thrombus source)
* Stroke (Cerebral Vascular Accident) AND age \< 20 years. Stroke is defined as a completed stroke with symptoms persisting for \> 24 hours and radiographic evidence of infarction by Computed Tomography or Magnetic Resonance Imaging. Transient Ischemic Attacks (TIA) are NOT eligible for this registry.
* Myocardial Infarction AND age \<20 years. Must have elevated cardiac enzymes (CK and/or Troponin) and Electrocardiographic (EKG) evidence meeting the local standard for diagnosis. Angina is NOT eligible for this registry.
Exclusion Criteria:
* Bleeding disorders
* Transient Ischemic Attack(s) (TIA)
* Sickle Cell Disease
* Mitochondrial Encephalopathy, Lactic Acidosis, and Stroke-Like Episodes (MELAS)
* Ornithine Transcarbamylase Deficiency
* Homocystinuria
* Other metabolic disorders known to be associated with Stroke
* Hemorrhagic Stroke
* Bacterial Endocarditis
* Microangiopathic Hemolytic Anemias (Thrombotic Thrombocytopenic Purpura or Hemolytic Uremic Syndrome)
* Patients greater than or equal to 20 years of age with Stroke or Myocardial Infarction (in order to limit confounding cardiovascular risk factors)
* Angina
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00266994
Study Brief:
Protocol Section:
NCT00266994