NCT00336570

Brief Summary

Principal Investigator: Arshed A. Quyyumi, MD To establish normal values by age, race, and gender of novel markers of risk in healthy subjects necessary to predict precise risk of cardiovascular disease in an individual.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
288

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Longer than P75 for all trials

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

Study Start

First participant enrolled

February 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2006

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

November 18, 2013

Status Verified

November 1, 2013

First QC Date

June 12, 2006

Last Update Submit

November 15, 2013

Conditions

Cardiovascular Diseases

Keywords

Oxidative StressEndothelial FunctionFlow Mediated Dilation

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy normal subjects between the ages of 30-90.

You may qualify if:

  • Ages 30-90.
  • Healthy normal performance status.
  • LDL cholesterol level \<120 mg/dl
  • Fasting blood glucose \<99 mg/dL
  • Blood pressure \<135 mmHg systolic and \<85 mmHg diastolic
  • Non-smoker for at least 5 years
  • BMI \>19 and \<26; stable body weight
  • Free of neurological and psychological (Axis I) disorders for at least three years.

You may not qualify if:

  • · Any oral antioxidants in the previous 2 weeks.
  • On lipid lowering medication in the past 8 weeks.
  • History of substance abuse.
  • Current neoplasm or history of neoplasia except basal cell cancer.
  • Any heart disease except for corrected congenital ht disease. History of neurological disease.
  • History of chronic GI disorders.
  • History of Rheumatologic disorders.
  • Known endocrine disorders.
  • History of Chronic Pulmonary diseases eg. COPD
  • Acute illness such as infection in the previous 4 weeks.
  • Creatinine \> 2
  • Liver enzymes \>1.5X normal.
  • Anemia (Hb \< 12.5) or chronic hematological disorder.
  • Physical limitation and sedentary status for any reason.
  • LDL cholesterol\>120.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

  • Jarrell ZR, Smith MR, Hu X, Orr M, Liu KH, Quyyumi AA, Jones DP, Go YM. Plasma acylcarnitine levels increase with healthy aging. Aging (Albany NY). 2020 Jun 16;12(13):13555-13570. doi: 10.18632/aging.103462. Epub 2020 Jun 16.

    PMID: 32554854DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood and Urine were collected. Samples of Serum, Plasma and Urine are stored.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Arshed A Quyyumi, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 12, 2006

First Posted

June 14, 2006

Study Start

February 1, 2006

Study Completion

October 1, 2010

Last Updated

November 18, 2013

Record last verified: 2013-11

Locations

US(1)