Risk factor profiling for future arterial cardiovascular events in patients wih unprovoked pulmonary embolism

Risk factor profiling for future arterial cardiovascular events in patients wih unprovoked pulmonary embolism - The Pythia Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34542

Enrollment

250

Registered

2010-12-15

Start date

2011-05-30

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pulmonary embolism venous embolism

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: unprovoked acute pulmonary embolism

Exclusion criteria

Exclusion criteria: 1. Acute onset of pulmonary embolism (PE) for more than 14 days 2. Provoked PE 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
Outcomes are documented arterial cardiovascular events occurring during follow-up: (fatal) acute coronary syndrome with or without PCI; (fatal) stroke, carotid endarterectomy, coronary artery bypass grafting, symptomatic peripheral arterial disease and sudden otherwise unexplained death. Non-fatal AMI is defined as the presence of at least two of the following criteria: (1) typical ischemic chest pain; (2) elevation of creatinine kinase (CK) enzyme or its MB fraction or troponin; (3) new ECG changes which include new or persistent ST/T changes, new BBB or new Q-waves in at least two consecutive leads. 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. Cardiovascular death is defined as any death from AMI, stroke or sudden otherwise unexplained death. Deaths are classified as cardiovascular, or due to cancer or other identifiable cause. Permission for autopsies is always sought for.	—

Measure

Time frame

Outcomes are documented arterial cardiovascular events occurring during follow-up: (fatal) acute coronary syndrome with or without PCI; (fatal) stroke, carotid endarterectomy, coronary artery bypass grafting, symptomatic peripheral arterial disease and sudden otherwise unexplained death. Non-fatal AMI is defined as the presence of at least two of the following criteria: (1) typical ischemic chest pain; (2) elevation of creatinine kinase (CK) enzyme or its MB fraction or troponin; (3) new ECG changes which include new or persistent ST/T changes, new BBB or new Q-waves in at least two consecutive leads. 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. Cardiovascular death is defined as any death from AMI, stroke or sudden otherwise unexplained death. Deaths are classified as cardiovascular, or due to cancer or other identifiable cause. Permission for autopsies is always sought for.

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Secondary

Measure	Time frame
N.A.	—

Countries

Netherlands

Outcome results