NCT00006295

Brief Summary

To study the genetic cause of low HDL-C, a risk factor for premature atherosclerotic vascular disease in patients with normal total cholesterol. The focus is primarily on the identification of a single mutation, as has been demonstrated in one family.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
370

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2000

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, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2000

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

5.9 years

First QC Date

September 25, 2000

Last Update Submit

January 10, 2020

Conditions

Cardiovascular DiseasesHeart DiseasesAtherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Gene discovery

    20 years

Study Arms (12)

Pedigree 1

Pedigree 2

Pedigree 3

Pedigree 4

Pedigree 5

Pedigree 6

Pedigree 7

Pedigree 8

Pedigree 9

Pedigree 10

Pedigree 11

Pedigree 12

Eligibility Criteria

AgeUp to 100 Years
Sexmale
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 (10)

  • Hong SH, Riley W, Rhyne J, Friel G, Miller M. Lack of association between increased carotid intima-media thickening and decreased HDL-cholesterol in a family with a novel ABCA1 variant, G2265T. Clin Chem. 2002 Nov;48(11):2066-70.

    PMID: 12407001BACKGROUND

  • Hong SH, Rhyne J, Zeller K, Miller M. ABCA1(Alabama): a novel variant associated with HDL deficiency and premature coronary artery disease. Atherosclerosis. 2002 Oct;164(2):245-50. doi: 10.1016/s0021-9150(02)00106-5.

    PMID: 12204794BACKGROUND

  • Ho Hong S, Rhyne J, Zeller K, Miller M. Novel ABCA1 compound variant associated with HDL cholesterol deficiency. Biochim Biophys Acta. 2002 May 21;1587(1):60-4. doi: 10.1016/s0925-4439(02)00066-2.

    PMID: 12009425BACKGROUND

  • Miller M, Zhan M, Georgopoulos A. Effect of desirable fasting triglycerides on the postprandial response to dietary fat. J Investig Med. 2003 Feb;51(1):50-5. doi: 10.2310/6650.2003.33544.

    PMID: 12580321BACKGROUND

  • Friend M, Vucenik I, Miller M. Research pointers: Platelet responsiveness to aspirin in patients with hyperlipidaemia. BMJ. 2003 Jan 11;326(7380):82-3. doi: 10.1136/bmj.326.7380.82. No abstract available.

    PMID: 12521973BACKGROUND

  • Miller M. Niacin as a component of combination therapy for dyslipidemia. Mayo Clin Proc. 2003 Jun;78(6):735-42. doi: 10.4065/78.6.735.

    PMID: 12934785BACKGROUND

  • Miller M, Zhan M. Genetic determinants of low high-density lipoprotein cholesterol. Curr Opin Cardiol. 2004 Jul;19(4):380-4. doi: 10.1097/01.hco.0000126584.12520.b5.

    PMID: 15218400BACKGROUND

  • Hong SH, Rhyne J, Miller M. Novel polypyrimidine variation (IVS46: del T -39...-46) in ABCA1 causes exon skipping and contributes to HDL cholesterol deficiency in a family with premature coronary disease. Circ Res. 2003 Nov 14;93(10):1006-12. doi: 10.1161/01.RES.0000102957.84247.8F. Epub 2003 Oct 23.

    PMID: 14576201BACKGROUND

  • Ahmad I, Zhan M, Miller M. High prevalence of C-reactive protein elevation with normal triglycerides (100-149 mg/dL): are triglyceride levels below 100 mg/dL more optimal in coronary heart disease risk assessment? Am J Med Sci. 2005 Apr;329(4):173-7. doi: 10.1097/00000441-200504000-00002.

    PMID: 15832099BACKGROUND

  • Miller M, Zhan M, Havas S. High attributable risk of elevated C-reactive protein level to conventional coronary heart disease risk factors: the Third National Health and Nutrition Examination Survey. Arch Intern Med. 2005 Oct 10;165(18):2063-8. doi: 10.1001/archinte.165.18.2063.

    PMID: 16216995BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesAtherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiovascular Medicine

Study Record Dates

First Submitted

September 25, 2000

First Posted

September 26, 2000

Study Start

August 1, 2000

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

January 14, 2020

Record last verified: 2020-01