NCT01569854

Brief Summary

The study intends to investigate whether genetics influence how individuals respond to statins (clinical outcomes and changes in carotid intimal media thickness)

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

March 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

4 years

First QC Date

March 30, 2012

Last Update Submit

September 26, 2016

Conditions

HyperlipidemiaHypercholesterolemiaDyslipidemia

Outcome Measures

Primary Outcomes (1)

  • carotid intimal media thickness (CIMT)

    CIMT measurements will be performed at baseline (within 3 months of starting statin) and at 6, 12, 18, and 24 months. Change in CIMT is considered a surogate measure of atherosclerotic progression.

    2 years

Study Arms (1)

statin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals will be recruited from various hospitals, ancillary clinics, and primary-care offices affiliated with the Ohio State University Medical Center (OSUMC).

You may qualify if:

  • recently (within past 3 months) started taking atorvastatin, lovastatin, or simvastatin

You may not qualify if:

  • concomitant uses of medications, supplements, or OTCs known to interfere with statin metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

nuclear pellet

MeSH Terms

Conditions

HyperlipidemiasHypercholesterolemiaDyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Joseph P Kitzmiller, MD PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 30, 2012

First Posted

April 3, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2016

Study Completion

March 1, 2022

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

US(1)