Pulmonary embolism Arterial cardiovascular events Risk factors
Conditions
Interventions
Baseline patient assessment:
Patients are asked for inclusion in the study ¡Ü 24h hours after diagnosis of PE. All arterial cardiovascular events that occur after inclusion will be scored. At baselin
Sponsors
Leiden University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: Consecutive patients presenting with an episode of unprovoked acute PE are potentially eligible for study inclusion. Acute PE is confirmed by at least one filling defect in the pulmonary arteries on CT scan or a high probability ventilation-perfusion (V/Q) lung scan. Unprovoked PE is defined as PE in absence of temporary risk factors (malignancy now or in previous 5 years, immobility > 3 days, recent long flight ( 18 years having given written informed consent are eligible for study inclusion. Patients may present as follows: 1. Presenting with suspected PE without clinical DVT; 2. Presenting with suspected PE and clinical symptoms of DVT: An ultrasound of the symptomatic leg is performed at baseline for proper comparison, should these patients at follow-up present with recurrent leg complaints; 3. Presenting with ultrasound proven DVT and concomitant clinical complains of PE: PE should be objectively proven before study inclusion.
Exclusion criteria
Exclusion criteria: 1. Acute onset of PE for more than 14 days; 2. Provoked PE (see criteria mentioned above); 3. Pregnancy; 4. Age less than 18 years; 5. Likelihood of non-compliance (e.g. no fixed address); 6. Life expectancy less than 3 months; 7. Failure to sign informed consent; 8. Diagnosis of PE during anticoagulant treatment; 9. Continuation of anticoagulation after the 6 months treatment period; 10. Participation in this study during a previous episode of acute PE.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the incidence of arterial cardiovascular events and deaths during the follow-up period. Arterial cardiovascular events are defined as: 1. (Fatal) acute coronary syndrome with or without PCI; Non-fatal AMI is defined as the presence of at least two of the following criteria: A. Typical ischemic chest pain; B. Elevation of creatinine kinase (CK) enzyme or its MB fraction or troponin; C. New EKG changes which include new or persistent ST/T changes, new BBB or new Q-waves in at least two consecutive leads. 2. (Fatal) stroke; Ischemic stroke is defined as the presence of a new focal neurological deficit, lasting for more than 24 hours. CT scans or MR images are required to exclude a non-ischemic origin of the neurological event; 3. Carotid endarterectomy; 4. Coronary artery bypass grafting; 5. Symptomatic peripheral arterial disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are the contributable arterial cardiovascular risk factors at baseline that may predict future arterial cardiovascular events. The cardiovascular risk factors measured at baseline are: 1. Medical and familial history; 2. Smoking status; 3. Medication use; 4. SCORE-score (lipids, blood pressure); 5. EKG; 6. Radiological imaging: Carotid ultrasound IMT and presence of plaque, Agatston¡¯s Calcium score; 7. D-dimer, Factor VIII, Mean platelet values, soluble P-selectin; 8. hs-CRP. | — |
Contacts
Public ContactM.V. Huisman
Leiden University Medical Center (LUMC) Department of Thrombosis and Haemostasis Room C4-68 P.O Box 9600
Outcome results
None listed