Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005338
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Homocysteine and Progression of Atherosclerosis
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:
2004-12
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:
In the first phase to establish the relationship of progression of peripheral vascular disease PVD to plasma homocysteine In the second phase to conduct a randomized controlled trial of folic acid treatment of plasma homocysteine in peripheral vascular disease
Detailed Description:
BACKGROUND
Few studies of progression of atherosclerotic peripheral vascular disease have been performed and none have used objective methods to evaluate disease progression in a large number of symptomatic subjects The study is of obvious major clinical importance Elevated plasma homocysteine is well established as an independent risk factor for atherosclerosis If folate treatment results in less frequentrapid progression of peripheral vascular disease then it will be confirmed as the first effective treatment for atherosclerosis which is without toxic side effects and does not involve major changes in lifedietary habits
DESIGN NARRATIVE
The Homocysteine and Progression of Atherosclerosis Study HPAS is a long term prospective blinded multifactoral clinical study which began in 1991 to study the relationship between elevated plasma homocysteine HC as well as a number of other risk factors and PVD progression The study is divided into two phases conducted sequentially upon 400 patients with symptomatic lower extremity LED and cerebrovascular disease CVD The first phase was a three year natural history study in which relationship of progression of peripheral vascular disease to plasma homocysteine and other risk factors was established The clinical question addressed by the natural history study was Do patients with symptomatic peripheral vascular disease and elevated plasma homocysteine have more rapidfrequent progression of peripheral vascular disease than patients with symptomatic peripheral vascular disease and normal plasma homocysteine Progression of disease was assessed by the primary outcome variables of ankle brachial pressure index and degree of carotid artery stenosis as determined in the noninvasive vascular laboratory and by secondary outcome variables including vascular death need for vascular surgery stroke myocardial infarction amputation and other clinical events All outcome variables were determined by investigators blinded to the results of plasma homocysteine testing
The second phase of the study which began in August 1995 is a blinded prospective randomized placebo-controlled trial of folic acid treatment of elevated plasma homocysteine in the same patient population Folic acid treatment has been demonstrated to result in normalization of elevated plasma homocysteine The treatment trial addresses the clinical question Do patients with symptomatic peripheral vascular disease and elevated plasma homocysteine treated with folate have less frequentrapid progression of peripheral vascular disease than patients with symptomatic peripheral vascular disease and elevated plasma homocysteine treated with placebo Although the second phase is described as a clinical trial the Surgery and Bioengineering Study Section describes it as clinical research not an NIH-defined Phase III trial
The study was renewed in FY 1999 through 2003 to continue follow-up and analysis
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Few studies of progression of atherosclerotic peripheral vascular disease have been performed and none have used objective methods to evaluate disease progression in a large number of symptomatic subjects The study is of obvious major clinical importance Elevated plasma homocysteine is well established as an independent risk factor for atherosclerosis If folate treatment results in less frequentrapid progression of peripheral vascular disease then it will be confirmed as the first effective treatment for atherosclerosis which is without toxic side effects and does not involve major changes in lifedietary habits
DESIGN NARRATIVE
The Homocysteine and Progression of Atherosclerosis Study HPAS is a long term prospective blinded multifactoral clinical study which began in 1991 to study the relationship between elevated plasma homocysteine HC as well as a number of other risk factors and PVD progression The study is divided into two phases conducted sequentially upon 400 patients with symptomatic lower extremity LED and cerebrovascular disease CVD The first phase was a three year natural history study in which relationship of progression of peripheral vascular disease to plasma homocysteine and other risk factors was established The clinical question addressed by the natural history study was Do patients with symptomatic peripheral vascular disease and elevated plasma homocysteine have more rapidfrequent progression of peripheral vascular disease than patients with symptomatic peripheral vascular disease and normal plasma homocysteine Progression of disease was assessed by the primary outcome variables of ankle brachial pressure index and degree of carotid artery stenosis as determined in the noninvasive vascular laboratory and by secondary outcome variables including vascular death need for vascular surgery stroke myocardial infarction amputation and other clinical events All outcome variables were determined by investigators blinded to the results of plasma homocysteine testing
The second phase of the study which began in August 1995 is a blinded prospective randomized placebo-controlled trial of folic acid treatment of elevated plasma homocysteine in the same patient population Folic acid treatment has been demonstrated to result in normalization of elevated plasma homocysteine The treatment trial addresses the clinical question Do patients with symptomatic peripheral vascular disease and elevated plasma homocysteine treated with folate have less frequentrapid progression of peripheral vascular disease than patients with symptomatic peripheral vascular disease and elevated plasma homocysteine treated with placebo Although the second phase is described as a clinical trial the Surgery and Bioengineering Study Section describes it as clinical research not an NIH-defined Phase III trial
The study was renewed in FY 1999 through 2003 to continue follow-up and analysis
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 |
|---|---|---|---|
| R01HL045267 | NIH | None | httpsreporternihgovquickSearchR01HL045267 |