NCT01406808

Brief Summary

The purpose of this study is to see if providing information to a person on their inherited (genetic) risk of cardiovascular disease (CVD) helps to motivate that person to change their diet, lifestyle or medication regimen to alter their risk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 28, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

October 5, 2017

Status Verified

October 1, 2017

Enrollment Period

5.2 years

First QC Date

July 28, 2011

Last Update Submit

October 3, 2017

Conditions

Coronary Artery Disease

Keywords

geneticatherosclerosismyocardial infarctionriskpreventive cardiology

Outcome Measures

Primary Outcomes (1)

  • change in LDL cholesterol

    6 mo

Secondary Outcomes (5)

  • change in weight

    6 mo

  • change in exercise

    6 mo

  • medication compliance

    6 mo

  • non-HDL cholesterol

    6 mo

  • blood pressure

    6 mo

Study Arms (2)

standard of care plus genetic information

OTHER
Behavioral: genetic risk score for coronary risk factors

usual standard of care without genetic information

NO INTERVENTION

Interventions

genetic risk score for coronary risk factorsBEHAVIORAL

genetic risk score based on coronary artery disease genetic risk variants (SNPs)

standard of care plus genetic information

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults age \> 18
  • Patient seeking cardiovascular risk evaluation
  • At intermediate (6-20%) or high risk (\> 20%) over 10 years of CAD as defined by Framingham 10 year risk score AND/OR at \> 20% risk of CAD over 30 years using the Framingham 30 year risk calculator
  • The genetic risk factors have been evaluated predominantly in white/European subjects. However, there is considerable overlap in the genetic architecture of South Asians and Hispanic/Latino populations. Therefore, we will limit our initial studies to these three race/ethnicity groups.

You may not qualify if:

  • History of myocardial infarction, angina, stroke, peripheral arterial disease, PCI, or CABG
  • Already on lipid lowering therapy
  • Anticipated survival \<1 year (e.g. metastatic cancer)
  • Serious conditions that would limit ability to adhere to recommendations (inability to take statins, exercise)
  • Already had genetic testing
  • Concurrent enrollment in another clinical trial
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Medical Center

Stanford, California, 94305, United States

Location

Related Publications (2)

  • Knowles JW, Assimes TL, Kiernan M, Pavlovic A, Goldstein BA, Yank V, McConnell MV, Absher D, Bustamante C, Ashley EA, Ioannidis JP. Randomized trial of personal genomics for preventive cardiology: design and challenges. Circ Cardiovasc Genet. 2012 Jun;5(3):368-76. doi: 10.1161/CIRCGENETICS.112.962746. No abstract available.

    PMID: 22715281BACKGROUND

  • Knowles JW, Zarafshar S, Pavlovic A, Goldstein BA, Tsai S, Li J, McConnell MV, Absher D, Ashley EA, Kiernan M, Ioannidis JPA, Assimes TL. Impact of a Genetic Risk Score for Coronary Artery Disease on Reducing Cardiovascular Risk: A Pilot Randomized Controlled Study. Front Cardiovasc Med. 2017 Aug 14;4:53. doi: 10.3389/fcvm.2017.00053. eCollection 2017.

    PMID: 28856136RESULT

MeSH Terms

Conditions

Coronary Artery DiseaseAtherosclerosisMyocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Joshua W. Knowles, MD-PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Themistocles L Assimes, MD-PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 28, 2011

First Posted

August 1, 2011

Study Start

August 1, 2011

Primary Completion

October 1, 2016

Study Completion

August 1, 2017

Last Updated

October 5, 2017

Record last verified: 2017-10

Locations

US(1)