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:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT04304651
Eligibility Criteria:
Inclusion Criteria:
Patients aged 50 years or older with a new diagnosis of first unprovoked proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE) will be eligible to participate into the study.
Unprovoked VTE is defined as the absence of any of the following predisposing factors:
1. active malignancy (known malignancy, progressive and/or treated during the last 5 years) except for adequately treated basal or squamous cell carcinoma; Patients whose state of health suggests the presence of cancer at the time of diagnosis of VTE cannot be included in the protocol
2. recent (less than 3 months) paralysis, paresis or plaster immobilization of the lower extremities;
3. recently bedridden for period of 3 or more days, or major surgery, within the previous 12 weeks requiring general or regional anaesthesia;
4. previous unprovoked VTE;
5. known thrombophilia (hereditary or acquired)
Exclusion Criteria:
Patients will be excluded from the study if they have any of the following criteria:
1. Refusal or inability to provide informed consent;
2. Hypersensitivity to 18F-FDG or any of the excipients according to the product monograph;
3. Unavailable to follow-up.
4. VTE while on anticoagulation (e.g apixaban, rivaroxaban, edoxaban, dabigatran, warfarin)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04304651
Study Brief:
Protocol Section:
NCT04304651