NCT01517113

Brief Summary

Background: \- Advancing age is associated with greater risk of heart disease. High blood pressure and hardening of the arteries also have more complications with age. Studies suggest that age-related inflammation may affect fatty tissue in the body. If this fat develops in the muscles or around the heart, it may increase risks of heart disease. Researchers will study body composition in older adults to see if age-related changes in body fat are related to higher risks of heart disease. Objectives: \- To study the relationship between fat deposits and aging, and greater risks of heart disease. Eligibility:

  • Participants in the Baltimore Longitudinal Study of Aging between 50 and 80 years of age.
  • Individuals between 50 and 80 years of age who have been diagnosed with coronary artery disease. Design:
  • Participants will be screened with a physical exam and medical history.
  • Participants will provide blood and urine samples. They will also have their height and weight measured. Waist circumference will also be taken.
  • Participants will have a DEXA scan to study their muscles.
  • Participants will have magnetic resonance imaging scans. These scans will study heart function and muscle and blood vessel health.
  • Participants with coronary artery disease will have catheterization. Blood samples will be collected during the procedure....

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

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

January 2, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2017

Completed
Last Updated

April 5, 2018

Status Verified

October 13, 2017

First QC Date

January 24, 2012

Last Update Submit

April 4, 2018

Conditions

Keywords

Endothelial DysfunctionHepaticAdiposityCytokinesMuscle MassCoronary Artery DiseaseAgingInflammation

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50-90 years
  • Body mass index greater than or equal to 20 and less than or equal to 35
  • Weight is less than 300 lbs
  • In addition, for CAD participants (Group B):
  • Catheterization-documented coronary artery disease, defined as greater than or equal to 70% stenosis in a major epicardial coronary artery, or greater than or equal to 50% stenosis of the left main coronary artery OR
  • Prior myocardial infarction defined by ischemic symptoms associated with ECG changes and enzyme elevation.
  • In addition, for CAD participants in whom arterial and hepatic vein inflammatory mediators will be obtained:
  • \- Scheduled for clinically indicated right or left heart catheterization, no contraindication for the procedure, and consented to the research procedure.

You may not qualify if:

  • Known inflammatory disease
  • Known liver disease
  • Abnormal liver function tests defined by enzyme rise to greater than three times the upper limit of normal.
  • Contraindications to the performance of MRI scans
  • Chronic use of anti-inflammatory agents other than low dose aspirin (81mg). Chronic use is defined here as the inability to stop taking their anti-inflammatory agent for at least one week before starting this study
  • Pregnant or lactating
  • In addition, for BLSA participants:
  • \- Known coronary artery disease by prior history, examination, or resting or stress electrocardiogram testing.
  • In addition, for CAD participants undergoing arterial and hepatic vein inflammatory mediator sampling:
  • Receiving therapy with heparin, a glycoprotein IIB/IIIA inhibitor, or bivalirudin
  • History of atrial fibrillation
  • Presence of an inferior vena cava filter
  • Deep venous thrombosis
  • Active infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

  • Singh T, Newman AB. Inflammatory markers in population studies of aging. Ageing Res Rev. 2011 Jul;10(3):319-29. doi: 10.1016/j.arr.2010.11.002. Epub 2010 Dec 8.

    PMID: 21145432BACKGROUND
  • Ferrucci L, Corsi A, Lauretani F, Bandinelli S, Bartali B, Taub DD, Guralnik JM, Longo DL. The origins of age-related proinflammatory state. Blood. 2005 Mar 15;105(6):2294-9. doi: 10.1182/blood-2004-07-2599. Epub 2004 Nov 30.

    PMID: 15572589BACKGROUND
  • Brooks GC, Blaha MJ, Blumenthal RS. Relation of C-reactive protein to abdominal adiposity. Am J Cardiol. 2010 Jul 1;106(1):56-61. doi: 10.1016/j.amjcard.2010.02.017. Epub 2010 May 13.

    PMID: 20609648BACKGROUND

MeSH Terms

Conditions

HypertensionAtherosclerosisObesityCoronary Artery DiseaseInflammation

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCoronary DiseaseMyocardial IschemiaHeart DiseasesPathologic Processes

Study Officials

  • Luigi Ferrucci, M.D.

    National Institute on Aging (NIA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2012

First Posted

January 25, 2012

Study Start

January 2, 2012

Study Completion

October 13, 2017

Last Updated

April 5, 2018

Record last verified: 2017-10-13

Locations