Incidence and Outcomes of Venous Thromboembolism
| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 25, 2000 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | August 1991 |
| Primary Completion Date | Not Provided |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT00005351 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Incidence and Outcomes of Venous Thromboembolism |
| Official Title ICMJE | Not Provided |
| Brief Summary | To identify the incidence cohort of Olmsted County Minnesota residents with deep venous thrombosis (DVT)/pulmonary embolism (PE) from 1966 through 1990. Episodes of DVT or PE acquired during hospitalization or in the community were identified for future studies. |
| Detailed Description | BACKGROUND: Deep vein thrombosis and pulmonary embolism most often occur during hospitalization for surgery or chronic medical conditions. Consequently information on deep venous thrombosis/pulmonary embolism is derived from large referral hospitals, and there are substantial gaps in our understanding of the incidence, risk factors, and outcomes of deep venous thrombosis/pulmonary embolism in the community. This was one of the first studies to compare hospital acquired deep venous thrombosis/pulmonary embolism with deep venous thrombosis/pulmonary embolism among ambulatory residents in a community. DESIGN NARRATIVE: The five part study: 1. identified the incidence cohort and tested the hypotheses that over the 25 year study period the incidence of deep venous thrombosis/pulmonary embolism had decreased, the extent of testing for suspected deep venous thrombosis/pulmonary embolism had increased, and the number of tests obtained for patients with deep venous thrombosis/pulmonary embolism had increased. 2. determined the independent risk factors for deep venous thrombosis/pulmonary embolism and estimated the population attribute risk due to each independent risk factor for deep venous thrombosis/pulmonary embolism in a case-control study of the incidence cohort and community controls. 3. tested the hypothesis that deep venous thrombosis/pulmonary embolism were independent risk factors for death after adjusting for age, sex and co-morbid conditions. 4. described the occurrence of the post-phlebitic syndrome, pulmonary hypertension, and recurrent deep venous thrombosis/pulmonary embolism over the 25 year study period and identified the independent risk factors for lower extremity venous ulceration. 5. evaluated the accuracy of national pulmonary embolism mortality rates by comparing pulmonary embolism mortality rates calculated from a review of all the inpatient and outpatient medical records of Olmsted County deep venous thrombosis/pulmonary embolism patients with death certificate pulmonary embolism mortality rates for Olmsted County from the National Center for Health Statistics. The study provided the most complete and comprehensive population based estimates of the incidence, risk factors, survival and outcomes of deep venous thrombosis/pulmonary embolism available to date. |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Case Control Observational Model: Natural History Time Perspective: Longitudinal |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Not Provided |
| Study Population | Not Provided |
| Condition ICMJE |
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| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Not Provided |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | Not Provided |
| Completion Date | July 1994 |
| Primary Completion Date | Not Provided |
| Eligibility Criteria ICMJE | No eligibility criteria |
| Gender | Male |
| Ages | Not Provided |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Not Provided |
| Administrative Information | |
| NCT Number ICMJE | NCT00005351 |
| Other Study ID Numbers ICMJE | 4226 |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Not Provided |
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) |
| Verification Date | September 2002 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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