NCT02245178

Brief Summary

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the United States, but markers that predict risk of developing disease outside of cigarette smoking have not been identified. Individuals with lung disease frequently have concurrent cardiovascular disease, but the reason for this is not well understood. In this study, we will identify markers that predict risk of future lung disease and evaluate the concurrent subclinical evolution of lung and heart dysfunction. This will allow for targeting of preventive strategies to stop the rising incidence of COPD and other lung diseases and provide insights into why heart and lung disease frequently occur together.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3,193

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

September 17, 2014

Last Update Submit

August 21, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incident COPD

    From cohort initiation, predictors of incident COPD

    30 years

Secondary Outcomes (1)

  • Incident restriction

    30 years

Study Arms (1)

Obervational - CARDIA participants

CARDIA study participants will undergo lung function testing and have existing thoracic CT scans analyzed for lung structure.

Procedure: Lung spirometryOther: CT scan analysis

Interventions

measurement of pulmonary function pre- and post-bronchodilator

Also known as: lung function
Obervational - CARDIA participants

Analysis of existing year 25 thoracic CT scans for lung and intrathoracic vascular structure

Obervational - CARDIA participants

Eligibility Criteria

Age48 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants in the main Coronary Artery Risk Development in Young Adults (CARDIA) cohort study attending the year 30 examination

You may qualify if:

  • Participation in the main CARDIA examination at year 30

You may not qualify if:

  • Shortness of breath with pain in the chest within the past week
  • Heart attack or stroke within the past month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Environment, ControlledEnvironmentEnvironment and Public Health

Study Officials

  • Ravi Kalhan, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 17, 2014

First Posted

September 19, 2014

Study Start

June 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2018

Last Updated

August 22, 2018

Record last verified: 2018-08