NCT00073788

Brief Summary

To evaluate Post-Traumatic Stress Disorder as a risk factor for cardiovascular disease in American Indians.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
267

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2003

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

September 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2003

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

June 2, 2014

Status Verified

May 1, 2014

Enrollment Period

4.9 years

First QC Date

December 8, 2003

Last Update Submit

May 30, 2014

Conditions

Cardiovascular DiseasesHeart Diseases

Outcome Measures

Primary Outcomes (3)

  • coronary flow reserve

    Measured by PET Scan. For coronary flow reserve, we will mainly focus on the overall measure of coronary flow reserve (as opposed to regional analysis), since this is thought to be appropriate for detection of early coronary disease.

    study visit

  • Heart Rate Variation (HRV)

    Measured by PET Scan. The main outcome for HRV will be the high frequency power.

    study visit

  • carotid intima-media thickness

    Measured by PET Scan and ultrasound. The main outcome of the carotid ultrasound will be the mean intima-media thickness on the far wall of the common carotid artery.

    study visit (PET scan)

Study Arms (2)

Subjects with PTSD

Subjects will be American Indian, between the ages of 18-68. Approximately 66% will be female, 33% male, which conforms to the distribution of PTSD in this population. Study group subjects will be PTSD positive. Overt CVD is exclusionary.

Procedure: PET Scans

Control Group

Subjects will be American Indian, between the ages of 18-68. Approximately 66% will be female, 33% male, which conforms to the distribution of PTSD in this population. Control subjects will be PTSD negative. For both groups: overt CVD is exclusionary.

Procedure: PET Scans

Interventions

PET ScansPROCEDURE

PET Scan to look for coronary flow reserve, heart rate variability, and carotid ultrasound measures (mean intermediate thickness of the far fall of the carotid artery).

Control GroupSubjects with PTSD

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

American Indian people with, and without, PTSD

You may qualify if:

  • be 18 years of age or older;
  • not be pregnant, or breastfeeding;
  • be free of heart disease when they participated in the American Indian Services Utilization, Psychiatric Epidemiology, Risk and Protective Factors Project (AI-SUPERPFP); or change in PTSD status from time of participation to completion of 2nd stage screening;
  • have no medical issues that interfere with the PET imaging such as unstable angina, myocardial infarction in the past week, severe obstructive lung disease, decompensated heart failure; severe coronary disease, severe stroke, or other medical conditions that would make it unsafe for them to travel and complete the protocol (e.g., not be on dialysis);
  • not be taking any medications such as theophylline or aminophylline or oral steroids (e.g. prednisone);
  • participants who use inhalers or nebulizers will be asked to use the inhalers or nebulizers in Denver on their regular schedule. If they are able to administer these treatments themselves on their regular schedule, they are eligible to be brought to Denver, assuming other eligibility criteria are met.
  • and not have any conditions or devices, like claustrophobia that would interfere with the heart imaging process.
  • not be using alcohol or any illegal substances during Denver visit and examination period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesHeart Diseases

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Spero M. Manson, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2003

First Posted

December 10, 2003

Study Start

September 1, 2003

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

June 2, 2014

Record last verified: 2014-05