Recruiting

Observational Study

Sponsor:

University of Oxford

Code:

NCT05169333

Conditions

Cardiovascular Diseases

Cardiovascular Risk Factors

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

ORFAN is a prospective, multi-centre, multi-ethnic cohort observational study collecting CT scans, biological material and outcomes data, to develop and validate novel biomarkers of cardiometabolic and other disease risk.

Conditions

Cardiovascular Diseases

Cardiovascular Risk Factors

Study ID

NCT05169333

Start date

Feb 23, 2016

Status verified date

Dec, 2024

Completion date

Feb, 2030

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Inclusion Criteria for study Arms 1, 2 and 3:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 -99 years.

Inclusion Criteria for study Arm 4:

• Male or Female, aged 18 -99 years.

Exclusion Criteria:

Exclusion Criteria for Study Arms 1, 2 and 3:

  • Unable or unwilling to consent
  • Active cancer

Exclusion Criteria for Study Arm 4:

  • Participation in Study Arms 1, 2 or 3
  • Existing opt-out from use of data for research purposes

Study Design

Enrollment

250000 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1

Participants attending cardiology department, hypertension or outpatient clinics.

Group 2

Participants who are recruited prospectively, during their clinically indicated CT scan, and they are followed-up prospectively for clinical endpoints; A follow-up CCTA at least 6 months later will be offered to a subgroup of these patients, to assess disease progression.

Group 3

Individuals where at least 6 months have elapsed from previous CCTA will undergo repeat CCTA scan and enter prospective follow up for clinical endpoints.

Group 4

Cohort of consecutive patients who have undergone clinical CTAs or unenhanced CT chest, abdomen and pelvis in the past, linking the index CT scan with prospective outcomes collection already accumulated.

Primary outcome measure

  • Cardiac and all cause mortality [ Time Frame: 15 years ]
  • Non-fatal vascular events [ Time Frame: 15 years ]
  • Cardiac and non-cardiac findings by Computed Tomography [ Time Frame: 15 years ]
  • Progression of disease [ Time Frame: 15 years ]

Central Contacts and Locations

Central contacts

Kenneth Chan, Dr

kenneth.chan@cardiov.ox.ac.uk

Ahmad Abdullrahman, Dr

orfan@cardiov.ox.ac.uk

Locations

Valleywise Health

Recruiting

Phoenix, Arizona, United States

Contacts

Nordstrom, Dr

Lora.Nordstrom@valleywisehealth.org

Yale University, School of Medicine

Recruiting

New Haven, Connecticut, United States

Contacts

Evangelos, Dr

evangelos.oikonomou@yale.edu

Bridging Medical Silos

Recruiting

Tampa, Florida, United States

Contacts

Ho, Dr

nickho@bridgingmedicalsilos.com

Emory University

Recruiting

Atlanta, Georgia, United States

Contacts

De Cecco, Prof

carlo.dececco@emory.edu

Midwest Heart & Vascular Specialists LLC

Recruiting

Kansas City, Kansas, United States

Contacts

Bloom, Dr

Stephen.Bloom@HCAHealthcare.com

St Luke's Hospital

Recruiting

Kansas City, Kansas, United States

Contacts

Centerp, Dr

Ehutt@saint-lukes.org

NIH National Heart, Lunch, and Blood Institute

Recruiting

Bethesda, Maryland, United States

Contacts

Mehta, Dr

nehal.mehta@nih.gov

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States

Contacts

Blankstein, Prof

rblankstein@bwh.harvard.edu

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States

Contacts

Desai, Prof

desaim2@ccf.org

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States

Contacts

Weber, Prof

Brittany.Weber@UTSouthwestern.edu

Brooke Army Medical Center (BAMC)

Recruiting

San Antonio, Texas, United States

University of Virginia

Recruiting

Charlottesville, Virginia, United States

Contacts

Villines, Prof

tv4bc@uvahealth.org

More Information

Sponsor

University of Oxford

Last update posted

Jul 31, 2026

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Oxford on 2026-07-31.