Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00035776
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2002-05-04
Brief Title:
Blood Factors and Peripheral Arterial Disease Outcomes
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 PADThe 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 12 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 015 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
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 PADThe 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 12 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 015 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL064739 | NIH | None | httpsreporternihgovquickSearchR01HL064739 |