Arterial Occlusive DiseasesNCT00035776
Blood Factors and Peripheral Arterial Disease Outcomes
An observational study of Arterial Occlusive Diseases and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To investigate associations between hemostatic and inflammatory blood factors and progression of lower extremity arterial ischemia and cardiovascular events in men and women with and without lower extremity peripheral arterial disease. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Arterial Occlusive Diseases, Cardiovascular Diseases, Peripheral Vascular Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2001to Dec 2005
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To investigate associations between hemostatic and inflammatory blood factors and progression of lower extremity arterial ischemia and cardiovascular events in men and women with and without lower extremity peripheral arterial disease.
Read the detailed description
BACKGROUND:
The pathophysiology of functional impairment in patients with lower extremity peripheral arterial disease (PAD) is not well understood. Although lower ankle brachial index (ABI) levels are associated with greater functional impairment, one study suggests that the ABI improves to a greater degree than functional impairment after lower extremity revascularization. A meta-analysis of exercise studies in intermittent claudication demonstrated no significant association between improved walking ability after exercise and change in calf blood flow or ABI. Thus, characteristics in addition to ABI appear to influence walking ability in PAD.
It has been hypothesized that chronic inflammation is a biological mechanism underlying the decline in physical function that occurs with aging. It was recently reported that higher levels of D-dimer (fibrin degradation product) and high-sensitivity C-reactive protein (hsCRP) are associated with greater objectively assessed functional limitations in persons with PAD, but functional limitations refer to specific abilities, such as objectively measured walking speed or balance, which are distinct from disability. Furthermore, functional limitations may not fully explain disability.
DESIGN NARRATIVE:
The prospective study assessed associations between hemostatic and inflammatory blood factors and progression of lower extremity arterial ischemia and cardiovascular events in 346 men and women with lower extremity peripheral arterial disease (PAD) and 203 men and women without PAD.The study was ancillary to an NHLBI funded prospective study of functional and cardiovascular outcomes in men and women with PAD, the Walking and Leg Circulation Study (WALCS). The blood factors under study which included fibrinogen, PAI-1, TPA antigen, d-dimer, prothrombin 1.2, and C-reactive protein (CRP), were associated with progression of coronary atherosclerosis in proposed models of the pathogenesis of coronary atherosclerosis, but were not well studied in PAD.
There were two specific aims. The first was to determine whether higher baseline blood factor levels were associated with a) progression of lower extremity arterial ischemia (decline in ankle brachial index >= 0.15, lower extremity gangrene, ulcer, revascularization, or amputation); b) functional decline over a 48 month follow-up. The second aim was to determine whether higher baseline blood factor levels were associated with new cardiovascular events over a 48 month follow-up. The hypothesis was that higher blood factor levels at baseline would be associated with PAD progression, functional decline, and higher rates of cardiovascular morbidity and mortality
Pilot data from the Cardiovascular Health Study (CHS) showed that relative risks of fibrinogen, D-dimer and CRP levels for cardiovascular events were highest for events occurring more proximate to baseline blood factor measurements. Therefore, the study also sought to determine whether blood factor levels measured at the most recent examination prior to cardiovascular events or PAD progression were higher than the levels that did not immediately precede cardiovascular events or PAD progression. The hypothesis was tested that blood factor levels at the most recent examination prior to cardiovascular events or PAD progression would be higher than blood factor levels that did not immediately precede cardiovascular events.
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
- Arterial Occlusive Diseases, Cardiovascular Diseases, Peripheral Vascular Diseases, Coronary Disease
- Medical subject headings
- Arterial Occlusive Diseases, Cardiovascular Diseases, Peripheral Vascular Diseases, Coronary Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2002 (estimated)
- Study startJan 2001
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Arterial Occlusive 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
- Mary McDermott, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035776
- Sponsor's protocol ID
- 1115
- Other IDs
- R01HL064739
- Status last verified
- Jan 2006
- First submitted
- 4 May 2002
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
McDermott MM, Guralnik JM, Greenland P, Pearce WH, Criqui MH, Liu K, Taylor L, Chan C, Sharma L, Schneider JR, Ridker PM, Green D, Quann M. Statin use and leg functioning in patients with and without lower-extremity peripheral arterial disease. Circulation. 2003 Feb 11;107(5):757-61. doi: 10.1161/01.cir.0000050380.64025.07.
PubMed 12578881McDermott MM, Green D, Greenland P, Liu K, Criqui MH, Chan C, Guralnik JM, Pearce WH, Ridker PM, Taylor L, Rifai N, Schneider JR. Relation of levels of hemostatic factors and inflammatory markers to the ankle brachial index. Am J Cardiol. 2003 Jul 15;92(2):194-9. doi: 10.1016/s0002-9149(03)00537-x.
PubMed 12860223McDermott MM, Greenland P, Green D, Guralnik JM, Criqui MH, Liu K, Chan C, Pearce WH, Taylor L, Ridker PM, Schneider JR, Martin G, Rifai N, Quann M, Fornage M. D-dimer, inflammatory markers, and lower extremity functioning in patients with and without peripheral arterial disease. Circulation. 2003 Jul 1;107(25):3191-8. doi: 10.1161/01.CIR.0000074227.53616.CC. Epub 2003 Jun 16.
PubMed 12810614McDermott MM, Guralnik JM, Greenland P, Green D, Liu K, Ridker PM, Chan C, Criqui MH, Ferrucci L, Taylor LM, Pearce WH, Schneider JR, Oskin SI. Inflammatory and thrombotic blood markers and walking-related disability in men and women with and without peripheral arterial disease. J Am Geriatr Soc. 2004 Nov;52(11):1888-94. doi: 10.1111/j.1532-5415.2004.52514.x.
PubMed 15507067McDermott MM, Greenland P, Guralnik JM, Ferrucci L, Green D, Liu K, Criqui MH, Schneider JR, Chan C, Ridker P, Pearce WH, Martin G, Clark E, Taylor L. Inflammatory markers, D-dimer, pro-thrombotic factors, and physical activity levels in patients with peripheral arterial disease. Vasc Med. 2004 May;9(2):107-15. doi: 10.1191/1358863x04vm525oa.
PubMed 15521700Shadman R, Criqui MH, Bundens WP, Fronek A, Denenberg JO, Gamst AC, McDermott MM. Subclavian artery stenosis: prevalence, risk factors, and association with cardiovascular diseases. J Am Coll Cardiol. 2004 Aug 4;44(3):618-23. doi: 10.1016/j.jacc.2004.04.044.
PubMed 15358030McDermott MM, Liu K, Greenland P, Guralnik JM, Criqui MH, Chan C, Pearce WH, Schneider JR, Ferrucci L, Celic L, Taylor LM, Vonesh E, Martin GJ, Clark E. Functional decline in peripheral arterial disease: associations with the ankle brachial index and leg symptoms. JAMA. 2004 Jul 28;292(4):453-61. doi: 10.1001/jama.292.4.453.
PubMed 15280343McDermott MM, Liu K, Ferrucci L, Criqui MH, Greenland P, Guralnik JM, Tian L, Schneider JR, Pearce WH, Tan J, Martin GJ. Physical performance in peripheral arterial disease: a slower rate of decline in patients who walk more. Ann Intern Med. 2006 Jan 3;144(1):10-20. doi: 10.7326/0003-4819-144-1-200601030-00005.
PubMed 16389250McDermott MM, Guralnik JM, Ferrucci L, Criqui MH, Greenland P, Tian L, Liu K, Tan J. Functional decline in lower-extremity peripheral arterial disease: associations with comorbidity, gender, and race. J Vasc Surg. 2005 Dec;42(6):1131-7. doi: 10.1016/j.jvs.2005.08.010.
PubMed 16376203McDermott MM, Ferrucci L, Liu K, Criqui MH, Greenland P, Green D, Guralnik JM, Ridker PM, Taylor LM, Rifai N, Tian L, Zheng J, Pearce WH, Schneider JR, Vonesh E. D-dimer and inflammatory markers as predictors of functional decline in men and women with and without peripheral arterial disease. J Am Geriatr Soc. 2005 Oct;53(10):1688-96. doi: 10.1111/j.1532-5415.2005.53510.x.
PubMed 16181167
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Factors and Peripheral Arterial Disease Outcomes
- ClinicalTrials.gov ID
- NCT00035776
- Acronym / sponsor ID
- 1115
- Conditions
- Arterial Occlusive Diseases, Cardiovascular Diseases, Peripheral Vascular Diseases, Coronary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jan 2001
- Study completion
- Dec 2005 (actual)
- First posted
- 6 May 2002 (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 associations between hemostatic and inflammatory blood factors and progression of lower extremity arterial ischemia and cardiovascular events in men and women with and without lower extremity peripheral arterial disease.
Detailed description
BACKGROUND:
The pathophysiology of functional impairment in patients with lower extremity peripheral arterial disease (PAD) is not well understood. Although lower ankle brachial index (ABI) levels are associated with greater functional impairment, one study suggests that the ABI improves to a greater degree than functional impairment after lower extremity revascularization. A meta-analysis of exercise studies in intermittent claudication demonstrated no significant association between improved walking ability after exercise and change in calf blood flow or ABI. Thus, characteristics in addition to ABI appear to influence walking ability in PAD.
It has been hypothesized that chronic inflammation is a biological mechanism underlying the decline in physical function that occurs with aging. It was recently reported that higher levels of D-dimer (fibrin degradation product) and high-sensitivity C-reactive protein (hsCRP) are associated with greater objectively assessed functional limitations in persons with PAD, but functional limitations refer to specific abilities, such as objectively measured walking speed or balance, which are distinct from disability. Furthermore, functional limitations may not fully explain disability.
DESIGN NARRATIVE:
The prospective study assessed associations between hemostatic and inflammatory blood factors and progression of lower extremity arterial ischemia and cardiovascular events in 346 men and women with lower extremity peripheral arterial disease (PAD) and 203 men and women without PAD.The study was ancillary to an NHLBI funded prospective study of functional and cardiovascular outcomes in men and women with PAD, the Walking and Leg Circulation Study (WALCS). The blood factors under study which included fibrinogen, PAI-1, TPA antigen, d-dimer, prothrombin 1.2, and C-reactive protein (CRP), were associated with progression of coronary atherosclerosis in proposed models of the pathogenesis of coronary atherosclerosis, but were not well studied in PAD.
There were two specific aims. The first was to determine whether higher baseline blood factor levels were associated with a) progression of lower extremity arterial ischemia (decline in ankle brachial index >= 0.15, lower extremity gangrene, ulcer, revascularization, or amputation); b) functional decline over a 48 month follow-up. The second aim was to determine whether higher baseline blood factor levels were associated with new cardiovascular events over a 48 month follow-up. The hypothesis was that higher blood factor levels at baseline would be associated with PAD progression, functional decline, and higher rates of cardiovascular morbidity and mortality
Pilot data from the Cardiovascular Health Study (CHS) showed that relative risks of fibrinogen, D-dimer and CRP levels for cardiovascular events were highest for events occurring more proximate to baseline blood factor measurements. Therefore, the study also sought to determine whether blood factor levels measured at the most recent examination prior to cardiovascular events or PAD progression were higher than the levels that did not immediately precede cardiovascular events or PAD progression. The hypothesis was tested that blood factor levels at the most recent examination prior to cardiovascular events or PAD progression would be higher than blood factor levels that did not immediately precede cardiovascular events.
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
- All
- 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 16 Mar 2016.
- Background: PubMed 12578881McDermott MM, Guralnik JM, Greenland P, Pearce WH, Criqui MH, Liu K, Taylor L, Chan C, Sharma L, Schneider JR, Ridker PM, Green D, Quann M. Statin use and leg functioning in patients with and without lower-extremity peripheral arterial disease. Circulation. 2003 Feb 11;107(5):757-61. doi: 10.1161/01.cir.0000050380.64025.07.
- Background: PubMed 12860223McDermott MM, Green D, Greenland P, Liu K, Criqui MH, Chan C, Guralnik JM, Pearce WH, Ridker PM, Taylor L, Rifai N, Schneider JR. Relation of levels of hemostatic factors and inflammatory markers to the ankle brachial index. Am J Cardiol. 2003 Jul 15;92(2):194-9. doi: 10.1016/s0002-9149(03)00537-x.
- Background: PubMed 12810614McDermott MM, Greenland P, Green D, Guralnik JM, Criqui MH, Liu K, Chan C, Pearce WH, Taylor L, Ridker PM, Schneider JR, Martin G, Rifai N, Quann M, Fornage M. D-dimer, inflammatory markers, and lower extremity functioning in patients with and without peripheral arterial disease. Circulation. 2003 Jul 1;107(25):3191-8. doi: 10.1161/01.CIR.0000074227.53616.CC. Epub 2003 Jun 16.
- Background: PubMed 15507067McDermott MM, Guralnik JM, Greenland P, Green D, Liu K, Ridker PM, Chan C, Criqui MH, Ferrucci L, Taylor LM, Pearce WH, Schneider JR, Oskin SI. Inflammatory and thrombotic blood markers and walking-related disability in men and women with and without peripheral arterial disease. J Am Geriatr Soc. 2004 Nov;52(11):1888-94. doi: 10.1111/j.1532-5415.2004.52514.x.
- Background: PubMed 15521700McDermott MM, Greenland P, Guralnik JM, Ferrucci L, Green D, Liu K, Criqui MH, Schneider JR, Chan C, Ridker P, Pearce WH, Martin G, Clark E, Taylor L. Inflammatory markers, D-dimer, pro-thrombotic factors, and physical activity levels in patients with peripheral arterial disease. Vasc Med. 2004 May;9(2):107-15. doi: 10.1191/1358863x04vm525oa.
- Background: PubMed 15358030Shadman R, Criqui MH, Bundens WP, Fronek A, Denenberg JO, Gamst AC, McDermott MM. Subclavian artery stenosis: prevalence, risk factors, and association with cardiovascular diseases. J Am Coll Cardiol. 2004 Aug 4;44(3):618-23. doi: 10.1016/j.jacc.2004.04.044.
- Background: PubMed 15280343McDermott MM, Liu K, Greenland P, Guralnik JM, Criqui MH, Chan C, Pearce WH, Schneider JR, Ferrucci L, Celic L, Taylor LM, Vonesh E, Martin GJ, Clark E. Functional decline in peripheral arterial disease: associations with the ankle brachial index and leg symptoms. JAMA. 2004 Jul 28;292(4):453-61. doi: 10.1001/jama.292.4.453.
- Background: PubMed 16389250McDermott MM, Liu K, Ferrucci L, Criqui MH, Greenland P, Guralnik JM, Tian L, Schneider JR, Pearce WH, Tan J, Martin GJ. Physical performance in peripheral arterial disease: a slower rate of decline in patients who walk more. Ann Intern Med. 2006 Jan 3;144(1):10-20. doi: 10.7326/0003-4819-144-1-200601030-00005.
- Background: PubMed 16376203McDermott MM, Guralnik JM, Ferrucci L, Criqui MH, Greenland P, Tian L, Liu K, Tan J. Functional decline in lower-extremity peripheral arterial disease: associations with comorbidity, gender, and race. J Vasc Surg. 2005 Dec;42(6):1131-7. doi: 10.1016/j.jvs.2005.08.010.
- Background: PubMed 16181167McDermott MM, Ferrucci L, Liu K, Criqui MH, Greenland P, Green D, Guralnik JM, Ridker PM, Taylor LM, Rifai N, Tian L, Zheng J, Pearce WH, Schneider JR, Vonesh E. D-dimer and inflammatory markers as predictors of functional decline in men and women with and without peripheral arterial disease. J Am Geriatr Soc. 2005 Oct;53(10):1688-96. doi: 10.1111/j.1532-5415.2005.53510.x.
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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.
Mary McDermott
Northwestern University
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Occlusive Diseases and Cardiovascular 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 16 Mar 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 NCT00035776, which also lists 10 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 16 Mar 2016.