Cardiovascular DiseasesNCT00011180
Risk Factors for Venous Thromboembolism in the Community
An observational study of Cardiovascular Diseases and Thromboembolism, run by Mayo Clinic at 1 site in United States.
Trial summary
To evaluate the trends in the incidence of venous thromboembolism, to determine the risk factors for venous thromboembolism in patients with medical and surgical illness, and to evaluate the efficacy of the anticoagulant therapy in reducing venous thromboembolism. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Thromboembolism
- How many people
- 385 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Using the data resouces of the Rochester Epidemiology Project, we will update the 1966-1995 inception cohort to include Olmsted County, Minnesota residents with with a first-lifetime deep vein thrombosis (DVT) or pulmonary embolism (PE) during the five year period, 1996-2000. All subjects will be followed forward in time through their linked medical records in the community (retrospective cohort study), until death or the most recent clinical contact. For each subject, all inpatient and outpatient medical records of any local health care provider will be searched for vital status at last clinical contact. For deceased patients, all death certificates will be reviewed regardless of the patient location at death. We also identified two Olmsted County residents (controls) without VTE matched by age and gender to each definite or probable case within the 1996-2000 cohort to perform a case-control study.
No eligibility criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subtherapeutic Heparin Anticoagulation as a Predictor of Recurrent Venous Thromboembolism: A Population-Based Cohort Study
To evaluate the trends in the incidence of venous thromboembolism, to determine the risk factors for venous thromboembolism in patients with medical and surgical illness, and to evaluate the efficacy of the anticoagulant therapy in reducing venous thromboembolism.
Read the detailed description
BACKGROUND:
Venous thromboembolism (VTE) occurs frequently among patients hospitalized for major surgery or hospitalized for a medical illness primarily due to prolonged duration of immobilization. However, many patients undergo major surgery without any occurrence of VTE. Standard prophylactic therapy after surgery is heparin, which reduces the risk of VTE. However, heparin is associated with bleeding complications. Thus, it would be desirable to identify patients at high risk for VTE who might benefit the most from heparin therapy. An important focus of the study is to look at genetic factors which might play an important role in VTE incidence.
DESIGN NARRATIVE:
The study is a population based, retrospective case and case-control investigation of the genetic and environmental determinants of venous thromboembolism in the Rochester Minnesota Olmsted County population. The first five years of the study had three specific aims. The first specific aim was to update the 1966-1995 inception cohort to include Olmsted County residents with VTE during the five year period, 1996-2000. The second aim was to extend the analysis of risk factors for VTE by identifying two Olmsted County residents (controls) without VTE matched by age and gender to each definite or probable case within the 1996-2000 cohort, and to obtain plasma and genomic DNA from all cases and controls and perform a case-control study. The third specific aim was to evaluate the efficacy of anticoagulant therapy to prevent VTE recurrence.
The study was extended through March, 2009 to investigate trends in the incidence of venous thromboembolism, new risk factors including lipid-lowering, beta-blocker, and ACE-inhibitor therapies, and introduction of low molecular weight heparin (LMWH) therapy.
- Conditions
- Cardiovascular Diseases, Thromboembolism
- Keywords
- Venous thromboembolism (VTE), Deep vein thrombosis (DVT), Pulmonary embolism (PE)
- Medical subject headings
- Cardiovascular Diseases, Thromboembolism, Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Incident Cohort with VTE | Olmsted County, Minnesota residents with with a first-lifetime deep vein thrombosis (DVT) or pulmonary embolism (PE) during the five year period, 1996-2000. | |
| Controls without VTE | Two Olmsted County, Minnesota residents without venous thromboembolism (VTE) were matched by age and gender to each definite or probable case of VTE within the 1996-2000 cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean time interval between commencing unfractionated heparin therapy and achieving a therapeutic activated partial thromboplastin time (aPTT)
The time interval (minutes) was measured retrospectively, using the electronic medical record for each subject.
Measured: Day 1 in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2001 (estimated)
- Study startApr 2001
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- John Heit, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011180
- Sponsor's protocol ID
- 864-98
- Other IDs
- R01HL066216
- Status last verified
- Dec 2012
- First submitted
- 13 Feb 2001
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Heit JA. Mapping out the future in venous thromboembolism and acute coronary syndromes. Semin Thromb Hemost. 2002 Aug;28 Suppl 3:33-9. doi: 10.1055/s-2002-34073.
PubMed 12232821Heit JA. Venous thromboembolism epidemiology: implications for prevention and management. Semin Thromb Hemost. 2002 Jun;28 Suppl 2:3-13. doi: 10.1055/s-2002-32312.
PubMed 12073175Heit JA, O'Fallon WM, Petterson TM, Lohse CM, Silverstein MD, Mohr DN, Melton LJ 3rd. Relative impact of risk factors for deep vein thrombosis and pulmonary embolism: a population-based study. Arch Intern Med. 2002 Jun 10;162(11):1245-8. doi: 10.1001/archinte.162.11.1245.
PubMed 12038942Heit JA. Perioperative management of the chronically anticoagulated patient. J Thromb Thrombolysis. 2001 Sep;12(1):81-7. doi: 10.1023/a:1012746729537.
PubMed 11711693Heit JA. Risk factors for venous thromboembolism. Clin Chest Med. 2003 Mar;24(1):1-12. doi: 10.1016/s0272-5231(02)00077-1.
PubMed 12685052Heit JA, Phelps MA, Ward SA, Slusser JP, Petterson TM, De Andrade M. Familial segregation of venous thromboembolism. J Thromb Haemost. 2004 May;2(5):731-6. doi: 10.1111/j.1538-7933.2004.00660.x.
PubMed 15099278Heit JA. Venous thromboembolism: disease burden, outcomes and risk factors. J Thromb Haemost. 2005 Aug;3(8):1611-7. doi: 10.1111/j.1538-7836.2005.01415.x.
PubMed 16102026Heit JA, Petterson TM, Owen WG, Burke JP, DE Andrade M, Melton LJ 3rd. Thrombomodulin gene polymorphisms or haplotypes as potential risk factors for venous thromboembolism: a population-based case-control study. J Thromb Haemost. 2005 Apr;3(4):710-7. doi: 10.1111/j.1538-7836.2005.01187.x.
PubMed 15842356Heit JA, Lahr BD, Petterson TM, Bailey KR, Ashrani AA, Melton LJ 3rd. Heparin and warfarin anticoagulation intensity as predictors of recurrence after deep vein thrombosis or pulmonary embolism: a population-based cohort study. Blood. 2011 Nov 3;118(18):4992-9. doi: 10.1182/blood-2011-05-357343. Epub 2011 Sep 2.
PubMed 21890644
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subtherapeutic Heparin Anticoagulation as a Predictor of Recurrent Venous Thromboembolism: A Population-Based Cohort Study
- ClinicalTrials.gov ID
- NCT00011180
- Acronym / sponsor ID
- 864-98
- Conditions
- Cardiovascular Diseases, Thromboembolism
- Keywords
- Venous thromboembolism (VTE), Deep vein thrombosis (DVT), Pulmonary embolism (PE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2001
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 13 Feb 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the trends in the incidence of venous thromboembolism, to determine the risk factors for venous thromboembolism in patients with medical and surgical illness, and to evaluate the efficacy of the anticoagulant therapy in reducing venous thromboembolism.
Detailed description
BACKGROUND:
Venous thromboembolism (VTE) occurs frequently among patients hospitalized for major surgery or hospitalized for a medical illness primarily due to prolonged duration of immobilization. However, many patients undergo major surgery without any occurrence of VTE. Standard prophylactic therapy after surgery is heparin, which reduces the risk of VTE. However, heparin is associated with bleeding complications. Thus, it would be desirable to identify patients at high risk for VTE who might benefit the most from heparin therapy. An important focus of the study is to look at genetic factors which might play an important role in VTE incidence.
DESIGN NARRATIVE:
The study is a population based, retrospective case and case-control investigation of the genetic and environmental determinants of venous thromboembolism in the Rochester Minnesota Olmsted County population. The first five years of the study had three specific aims. The first specific aim was to update the 1966-1995 inception cohort to include Olmsted County residents with VTE during the five year period, 1996-2000. The second aim was to extend the analysis of risk factors for VTE by identifying two Olmsted County residents (controls) without VTE matched by age and gender to each definite or probable case within the 1996-2000 cohort, and to obtain plasma and genomic DNA from all cases and controls and perform a case-control study. The third specific aim was to evaluate the efficacy of anticoagulant therapy to prevent VTE recurrence.
The study was extended through March, 2009 to investigate trends in the incidence of venous thromboembolism, new risk factors including lipid-lowering, beta-blocker, and ACE-inhibitor therapies, and introduction of low molecular weight heparin (LMWH) therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incident Cohort with VTE | – | –Olmsted County, Minnesota residents with with a first-lifetime deep vein thrombosis (DVT) or pulmonary embolism (PE) during the five year period, 1996-2000. |
| Controls without VTE | – | –Two Olmsted County, Minnesota residents without venous thromboembolism (VTE) were matched by age and gender to each definite or probable case of VTE within the 1996-2000 cohort. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Using the data resouces of the Rochester Epidemiology Project, we will update the 1966-1995 inception cohort to include Olmsted County, Minnesota residents with with a first-lifetime deep vein thrombosis (DVT) or pulmonary embolism (PE) during the five year period, 1996-2000. All subjects will be followed forward in time through their linked medical records in the community (retrospective cohort study), until death or the most recent clinical contact. For each subject, all inpatient and outpatient medical records of any local health care provider will be searched for vital status at last clinical contact. For deceased patients, all death certificates will be reviewed regardless of the patient location at death. We also identified two Olmsted County residents (controls) without VTE matched by age and gender to each definite or probable case within the 1996-2000 cohort to perform a case-control study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean time interval between commencing unfractionated heparin therapy and achieving a therapeutic activated partial thromboplastin time (aPTT)
Time frame: Day 1 in hospital
The time interval (minutes) was measured retrospectively, using the electronic medical record for each subject.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
- Background: PubMed 12232821Heit JA. Mapping out the future in venous thromboembolism and acute coronary syndromes. Semin Thromb Hemost. 2002 Aug;28 Suppl 3:33-9. doi: 10.1055/s-2002-34073.
- Background: PubMed 12073175Heit JA. Venous thromboembolism epidemiology: implications for prevention and management. Semin Thromb Hemost. 2002 Jun;28 Suppl 2:3-13. doi: 10.1055/s-2002-32312.
- Background: PubMed 12038942Heit JA, O'Fallon WM, Petterson TM, Lohse CM, Silverstein MD, Mohr DN, Melton LJ 3rd. Relative impact of risk factors for deep vein thrombosis and pulmonary embolism: a population-based study. Arch Intern Med. 2002 Jun 10;162(11):1245-8. doi: 10.1001/archinte.162.11.1245.
- Background: PubMed 11711693Heit JA. Perioperative management of the chronically anticoagulated patient. J Thromb Thrombolysis. 2001 Sep;12(1):81-7. doi: 10.1023/a:1012746729537.
- Background: PubMed 12685052Heit JA. Risk factors for venous thromboembolism. Clin Chest Med. 2003 Mar;24(1):1-12. doi: 10.1016/s0272-5231(02)00077-1.
- Background: PubMed 15099278Heit JA, Phelps MA, Ward SA, Slusser JP, Petterson TM, De Andrade M. Familial segregation of venous thromboembolism. J Thromb Haemost. 2004 May;2(5):731-6. doi: 10.1111/j.1538-7933.2004.00660.x.
- Background: PubMed 16102026Heit JA. Venous thromboembolism: disease burden, outcomes and risk factors. J Thromb Haemost. 2005 Aug;3(8):1611-7. doi: 10.1111/j.1538-7836.2005.01415.x.
- Background: PubMed 15842356Heit JA, Petterson TM, Owen WG, Burke JP, DE Andrade M, Melton LJ 3rd. Thrombomodulin gene polymorphisms or haplotypes as potential risk factors for venous thromboembolism: a population-based case-control study. J Thromb Haemost. 2005 Apr;3(4):710-7. doi: 10.1111/j.1538-7836.2005.01187.x.
- Background: PubMed 21890644Heit JA, Lahr BD, Petterson TM, Bailey KR, Ashrani AA, Melton LJ 3rd. Heparin and warfarin anticoagulation intensity as predictors of recurrence after deep vein thrombosis or pulmonary embolism: a population-based cohort study. Blood. 2011 Nov 3;118(18):4992-9. doi: 10.1182/blood-2011-05-357343. Epub 2011 Sep 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Heit, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Thromboembolism, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean time interval between commencing unfractionated heparin therapy and achieving a therapeutic activated partial thromboplastin time (aPTT) (time frame: Day 1 in hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00011180, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2012.