Cardiovascular DiseasesNCT00005356
Novel Hemostatic Cardiac Risk Factors in Framingham
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To investigate hemostatic variables in relation to cardiovascular risk in the Framingham Offspring Study cohort. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Death, Sudden, Cardiac
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1994to May 1998
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To investigate hemostatic variables in relation to cardiovascular risk in the Framingham Offspring Study cohort.
Read the detailed description
BACKGROUND:
Elevation of platelet reactivity plasminogen activator inhibitor, fibrinogen, von Willebrand's factor, and factor VII have been reported to increase myocardial infarction risk. Myocardial infarction and sudden cardiac death are more frequent in the morning when platelet activity is increased and fibrinolysis is decreased. Reduction of recurrent myocardial infarction by aspirin and coumadin suggests causal roles for platelet activity and coagulation. Increases in viscosity and decreases in anti-thrombin III and Protein C have been linked with increased thrombosis. Despite these findings, a coherent picture of these disparate hemostatic indices as cardiac risk factors has yet to emerge.
DESIGN NARRATIVE:
Platelet reactivty, plasminogen activatator inhibitor, fibrinogen, von Willebrand's factor, factor VII, and other hemostatic risk factors were measured in all 4,000 subjects of the Framingham Offspring Study. The data were combined with the regularly collected Framingham data to: determine the relationships between hemostatic factors and carotid atherosclerosis as assessed by ultrasound; determine the relationship between hemostatic factors and the traditional cardiac risk factors; and determine if hemostatic risk factors independently predict myocardial infarction and cardiac death.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Death, Sudden, Cardiac, Myocardial Infarction, Thrombosis, Atherosclerosis
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Death, Sudden, Cardiac, Myocardial Infarction, Thrombosis, Atherosclerosis, Carotid Artery Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1994
- Study completionMay 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 National Heart, Lung, and Blood Institute (NHLBI)The 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Geoffrey Tofler, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005356
- Sponsor's protocol ID
- 4242
- Other IDs
- R01HL048157
- Status last verified
- Mar 2005
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Welty FK, Mittleman MA, Wilson PW, Sutherland PA, Matheney TH, Lipinska I, Muller JE, Levy D, Tofler GH. Hypobetalipoproteinemia is associated with low levels of hemostatic risk factors in the Framingham offspring population. Circulation. 1997 Feb 18;95(4):825-30. doi: 10.1161/01.cir.95.4.825.
PubMed 9054738Rosito GB, Tofler GH. Hemostatic factors as triggers of cardiovascular events. Cardiol Clin. 1996 May;14(2):239-50. doi: 10.1016/s0733-8651(05)70277-0.
PubMed 8724556Poli KA, Tofler GH, Larson MG, Evans JC, Sutherland PA, Lipinska I, Mittleman MA, Muller JE, D'Agostino RB, Wilson PW, Levy D. Association of blood pressure with fibrinolytic potential in the Framingham offspring population. Circulation. 2000 Jan 25;101(3):264-9. doi: 10.1161/01.cir.101.3.264.
PubMed 10645922Meigs JB, Mittleman MA, Nathan DM, Tofler GH, Singer DE, Murphy-Sheehy PM, Lipinska I, D'Agostino RB, Wilson PW. Hyperinsulinemia, hyperglycemia, and impaired hemostasis: the Framingham Offspring Study. JAMA. 2000 Jan 12;283(2):221-8. doi: 10.1001/jama.283.2.221.
PubMed 10634338Gebara OC, Mittleman MA, Sutherland P, Lipinska I, Matheney T, Xu P, Welty FK, Wilson PW, Levy D, Muller JE, et al. Association between increased estrogen status and increased fibrinolytic potential in the Framingham Offspring Study. Circulation. 1995 Apr 1;91(7):1952-8. doi: 10.1161/01.cir.91.7.1952.
PubMed 7895352
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Hemostatic Cardiac Risk Factors in Framingham
- ClinicalTrials.gov ID
- NCT00005356
- Acronym / sponsor ID
- 4242
- Conditions
- Cardiovascular Diseases, Heart Diseases, Death, Sudden, Cardiac, Myocardial Infarction, Thrombosis, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1994
- Study completion
- May 1998 (actual)
- First posted
- 26 May 2000 (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 investigate hemostatic variables in relation to cardiovascular risk in the Framingham Offspring Study cohort.
Detailed description
BACKGROUND:
Elevation of platelet reactivity plasminogen activator inhibitor, fibrinogen, von Willebrand's factor, and factor VII have been reported to increase myocardial infarction risk. Myocardial infarction and sudden cardiac death are more frequent in the morning when platelet activity is increased and fibrinolysis is decreased. Reduction of recurrent myocardial infarction by aspirin and coumadin suggests causal roles for platelet activity and coagulation. Increases in viscosity and decreases in anti-thrombin III and Protein C have been linked with increased thrombosis. Despite these findings, a coherent picture of these disparate hemostatic indices as cardiac risk factors has yet to emerge.
DESIGN NARRATIVE:
Platelet reactivty, plasminogen activatator inhibitor, fibrinogen, von Willebrand's factor, factor VII, and other hemostatic risk factors were measured in all 4,000 subjects of the Framingham Offspring Study. The data were combined with the regularly collected Framingham data to: determine the relationships between hemostatic factors and carotid atherosclerosis as assessed by ultrasound; determine the relationship between hemostatic factors and the traditional cardiac risk factors; and determine if hemostatic risk factors independently predict myocardial infarction and cardiac death.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 18 Feb 2016.
- Background: PubMed 9054738Welty FK, Mittleman MA, Wilson PW, Sutherland PA, Matheney TH, Lipinska I, Muller JE, Levy D, Tofler GH. Hypobetalipoproteinemia is associated with low levels of hemostatic risk factors in the Framingham offspring population. Circulation. 1997 Feb 18;95(4):825-30. doi: 10.1161/01.cir.95.4.825.
- Background: PubMed 8724556Rosito GB, Tofler GH. Hemostatic factors as triggers of cardiovascular events. Cardiol Clin. 1996 May;14(2):239-50. doi: 10.1016/s0733-8651(05)70277-0.
- Background: PubMed 10645922Poli KA, Tofler GH, Larson MG, Evans JC, Sutherland PA, Lipinska I, Mittleman MA, Muller JE, D'Agostino RB, Wilson PW, Levy D. Association of blood pressure with fibrinolytic potential in the Framingham offspring population. Circulation. 2000 Jan 25;101(3):264-9. doi: 10.1161/01.cir.101.3.264.
- Background: PubMed 10634338Meigs JB, Mittleman MA, Nathan DM, Tofler GH, Singer DE, Murphy-Sheehy PM, Lipinska I, D'Agostino RB, Wilson PW. Hyperinsulinemia, hyperglycemia, and impaired hemostasis: the Framingham Offspring Study. JAMA. 2000 Jan 12;283(2):221-8. doi: 10.1001/jama.283.2.221.
- Background: PubMed 7895352Gebara OC, Mittleman MA, Sutherland P, Lipinska I, Matheney T, Xu P, Welty FK, Wilson PW, Levy D, Muller JE, et al. Association between increased estrogen status and increased fibrinolytic potential in the Framingham Offspring Study. Circulation. 1995 Apr 1;91(7):1952-8. doi: 10.1161/01.cir.91.7.1952.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Geoffrey Tofler
Beth Israel Deaconess Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005356, which also lists 5 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 18 Feb 2016.