NCT00005338

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 1991

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1991

Completed
8.8 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2000

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

February 18, 2016

Status Verified

December 1, 2004

First QC Date

May 25, 2000

Last Update Submit

February 17, 2016

Conditions

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
No eligibility criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (21)

  • McLafferty RB, Moneta GL, Passman MA, Brant BM, Taylor LM Jr, Porter JM. Late clinical and hemodynamic sequelae of isolated calf vein thrombosis. J Vasc Surg. 1998 Jan;27(1):50-6; discussion 56-7. doi: 10.1016/s0741-5214(98)70291-5.

    PMID: 9474082BACKGROUND
  • Nehler MR, Taylor LM Jr, Porter JM. Homocysteinemia as a risk factor for atherosclerosis: a review. Cardiovasc Surg. 1997 Dec;5(6):559-67. doi: 10.1016/s0967-2109(97)00062-8.

    PMID: 9423939BACKGROUND
  • Abou-Zamzam AM Jr, Lee RW, Moneta GL, Taylor LM Jr, Porter JM. Functional outcome after infrainguinal bypass for limb salvage. J Vasc Surg. 1997 Feb;25(2):287-95; discussion 295-7. doi: 10.1016/s0741-5214(97)70350-1.

    PMID: 9052563BACKGROUND
  • Lee RW, Taylor LM Jr, Landry GJ, Goodnight SH, Moneta GL, Edwards JM, Yeager RA, Porter JM. Prospective comparison of infrainguinal bypass grafting in patients with and without antiphospholipid antibodies. J Vasc Surg. 1996 Oct;24(4):524-31; discussion 531-3. doi: 10.1016/s0741-5214(96)70068-x.

    PMID: 8911401BACKGROUND
  • McLafferty RB, Moneta GL, Masser PA, Taylor LM Jr, Porter JM. Progression of atherosclerosis in arteries distal to lower extremity revascularizations. J Vasc Surg. 1995 Oct;22(4):450-5; discussion 455-6. doi: 10.1016/s0741-5214(95)70014-5.

    PMID: 7563406BACKGROUND
  • McLafferty RB, Moneta GL, Taylor LM Jr, Porter JM. Ability of ankle-brachial index to detect lower-extremity atherosclerotic disease progression. Arch Surg. 1997 Aug;132(8):836-40; discussion 840-1. doi: 10.1001/archsurg.1997.01430320038005.

    PMID: 9267266BACKGROUND
  • Deloughery TG, Evans A, Sadeghi A, McWilliams J, Henner WD, Taylor LM Jr, Press RD. Common mutation in methylenetetrahydrofolate reductase. Correlation with homocysteine metabolism and late-onset vascular disease. Circulation. 1996 Dec 15;94(12):3074-8. doi: 10.1161/01.cir.94.12.3074.

    PMID: 8989110BACKGROUND
  • Nehler MR, Moneta GL, Lee RW, Edwards JM, Taylor LM Jr, Porter JM. Improving selection of patients with less than 60% asymptomatic internal carotid artery stenosis for follow-up carotid artery duplex scanning. J Vasc Surg. 1996 Oct;24(4):580-5; discussion 585-7. doi: 10.1016/s0741-5214(96)70073-3.

    PMID: 8911406BACKGROUND
  • Masser PA, Taylor LM Jr, Porter JM. Importance of elevated plasma homocysteine levels as a risk factor for atherosclerosis. Ann Thorac Surg. 1994 Oct;58(4):1240-6. doi: 10.1016/0003-4975(94)90522-3.

    PMID: 7944799BACKGROUND
  • Taylor LM Jr, Chitwood RW, Dalman RL, Sexton G, Goodnight SH, Porter JM. Antiphospholipid antibodies in vascular surgery patients. A cross-sectional study. Ann Surg. 1994 Oct;220(4):544-50; discussion 550-1. doi: 10.1097/00000658-199410000-00012.

    PMID: 7944664BACKGROUND
  • Taylor LM Jr, Park TC, Edwards JM, Yeager RA, McConnell DC, Moneta GA, Porter JM. Acute disruption of polytetrafluoroethylene grafts adjacent to axillary anastomoses: a complication of axillofemoral grafting. J Vasc Surg. 1994 Oct;20(4):520-6; discussion 526-8. doi: 10.1016/0741-5214(94)90276-3.

    PMID: 7933253BACKGROUND
  • Jacobsen DW, Gatautis VJ, Green R, Robinson K, Savon SR, Secic M, Ji J, Otto JM, Taylor LM Jr. Rapid HPLC determination of total homocysteine and other thiols in serum and plasma: sex differences and correlation with cobalamin and folate concentrations in healthy subjects. Clin Chem. 1994 Jun;40(6):873-81.

    PMID: 8087981BACKGROUND
  • Taylor LM Jr, Porter JM. Elevated plasma homocysteine as a risk factor for atherosclerosis. Semin Vasc Surg. 1993 Mar;6(1):36-45. No abstract available.

    PMID: 8252227BACKGROUND
  • Nicoloff AD, Taylor LM Jr, McLafferty RB, Moneta GL, Porter JM. Patient recovery after infrainguinal bypass grafting for limb salvage. J Vasc Surg. 1998 Feb;27(2):256-63; discussion 264-6. doi: 10.1016/s0741-5214(98)70356-8.

    PMID: 9510280BACKGROUND
  • Taylor LM Jr, Moneta GL, Sexton GJ, Schuff RA, Porter JM. Prospective blinded study of the relationship between plasma homocysteine and progression of symptomatic peripheral arterial disease. J Vasc Surg. 1999 Jan;29(1):8-19; discussion 19-21. doi: 10.1016/s0741-5214(99)70345-9.

    PMID: 9925456BACKGROUND
  • Cipolla MJ, Williamson WK, Nehler ML, Taylor LM Jr, Porter JM. The effect of elevated homocysteine levels on adrenergic vasoconstriction of human resistance arteries: the role of the endothelium and reactive oxygen species. J Vasc Surg. 2000 Apr;31(4):751-9. doi: 10.1067/mva.2000.103797.

    PMID: 10753283BACKGROUND
  • Lovelace TD, Moneta GL, Abou-Zamzam AM Jr, Edwards JM, Yeager RA, Landry GJ, Taylor LM Jr, Porter JM. Optimizing duplex follow-up in patients with an asymptomatic internal carotid artery stenosis of less than 60%. J Vasc Surg. 2001 Jan;33(1):56-61. doi: 10.1067/mva.2001.112303.

    PMID: 11137924BACKGROUND
  • Nicoloff AD, Taylor LM Jr, Sexton GJ, Schuff RA, Edwards JM, Yeager RA, Landry GJ, Moneta GL, Porter JM; Homocysteine and Progression of Atherosclerosis Study Investigators. Relationship between site of initial symptoms and subsequent progression of disease in a prospective study of atherosclerosis progression in patients receiving long-term treatment for symptomatic peripheral arterial disease. J Vasc Surg. 2002 Jan;35(1):38-46; discussion 46-7.

    PMID: 11802131BACKGROUND
  • Giswold ME, Landry GJ, Sexton GJ, Yeager RA, Edwards JM, Taylor LM Jr, Moneta GL. Modifiable patient factors are associated with reverse vein graft occlusion in the era of duplex scan surveillance. J Vasc Surg. 2003 Jan;37(1):47-53. doi: 10.1067/mva.2003.4.

    PMID: 12514577BACKGROUND
  • Cook JW, Taylor LM, Orloff SL, Landry GJ, Moneta GL, Porter JM. Homocysteine and arterial disease. Experimental mechanisms. Vascul Pharmacol. 2002 May;38(5):293-300. doi: 10.1016/s1537-1891(02)00254-9.

    PMID: 12487034BACKGROUND
  • Taylor LM Jr. Elevated plasma homocysteine as risk factor for peripheral arterial disease--what is the evidence? Semin Vasc Surg. 2003 Sep;16(3):215-22. doi: 10.1016/s0895-7967(03)00027-9.

    PMID: 12975761BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesPeripheral Vascular DiseasesAtherosclerosisCerebrovascular DisordersMyocardial InfarctionHeart DiseasesHyperhomocysteinemia

Condition Hierarchy (Ancestors)

Vascular DiseasesArteriosclerosisArterial Occlusive DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMyocardial IschemiaInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMalabsorption SyndromesMetabolic DiseasesNutritional and Metabolic DiseasesVitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Study Officials

  • Lloyd Taylor

    Oregon Health and Science University

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

August 1, 1991

Study Completion

August 1, 2004

Last Updated

February 18, 2016

Record last verified: 2004-12