NCT05009589

Brief Summary

This study will screen for the presence of cardiovascular disease and provide education about the signs and symptoms of cardiovascular disease and heart disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
552

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

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

July 14, 2021

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2022

Completed
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

August 4, 2021

Last Update Submit

January 3, 2023

Conditions

Cardiovascular DiseasesHeart Diseases

Outcome Measures

Primary Outcomes (3)

  • Abnormal structural heart findings

    The number of patients with abnormal structural heart findings as identified by echocardiography

    30 days

  • Abnormal electrocardiography findings

    The number of patients with abnormal electrocardiography findings such as rhythm disturbances, bundle branch or fascicular block, or other conduction delays

    30 days

  • Risk factors associated with cardiovascular disease

    Risk factors associated with cardiovascular disease including obesity (BMI and BSA calculations using height and weight) and blood pressure, along with personal and familial medical history.

    30 days

Eligibility Criteria

Age50 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will include participants identified at pre-planned screening events for cardiovascular disease who provide informed consent.

Key Eligibility Criteria: 1. at least 50 years of age on the day of the screening event 2. informed of the nature of the study, agrees to its provisions, and has provided written informed consent 3. does not have any conditions that would interfere with obtaining an echocardiogram of the heart

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Lifewellness Institute

San Diego, California, 92106, United States

Location

Related Publications (1)

  • Okoh AK, Amponsah MKD, Cheffet-Walsh S, Patel M, Carfagno D, Linton D, Dimeff R, Braunreiter D, Harrington P, Brennan FH Jr, Kavinsky C, Everett M, Park B, Gunnarsson M, Snowden S, Mootz L, Koepnick T, Wheeler J, Clarke SE, Prince H, Sannino A, Grayburn P, Rice EL. Prevalence of Cardiovascular Disease and Risk Factors Among Former National Football League Players. J Am Coll Cardiol. 2024 May 14;83(19):1827-1837. doi: 10.1016/j.jacc.2024.03.371. Epub 2024 Apr 7.

    PMID: 38593943DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesHeart Diseases

Study Officials

  • E. Lee Rice, MD

    Lifewellness Institute, San Diego, CA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2021

First Posted

August 17, 2021

Study Start

July 14, 2021

Primary Completion

October 7, 2022

Study Completion

October 7, 2022

Last Updated

January 5, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)