Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217178
Status:
UNKNOWN
Last Update Posted:
2005-09-22
First Post:
2005-09-16
Brief Title:
Homocysteine Lowering and Atherosclerosis Reduction Trial HART
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
Homocysteine Lowering and Atherosclerosis Reduction Trial HART
Status:
UNKNOWN
Status Verified Date:
2004-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Study Objective
1 To evaluate whether combined therapy with folic acid 25 mgday vitamin B6 50 mgday and vitamin B12 1000 microgramsday vs placebo reduces the rate of atherosclerosis progression as evaluated by quantitative B-mode carotid ultrasound US
1 To evaluate whether combined therapy with folic acid 25 mgday vitamin B6 50 mgday and vitamin B12 1000 microgramsday vs placebo reduces the rate of atherosclerosis progression as evaluated by quantitative B-mode carotid ultrasound US
Detailed Description:
The HART study is designed as a substudy of the Heart Outcomes Prevention Evaluation-2 HOPE-2trial which evaluates the effect of combined therapy folic acid and vitamin B6 and B12 on clinical events The study is designed to enrol 900 study participants randomized to homocysteine lowering therapies or placebo Follow-up will estimate over 5 years Study participants will undergo yearly carotid B-Mode ultrasound examinations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIHR MCT 44159 | None | None | None |