The Oxford Risk Factors And Non-Invasive Imaging Study (ORFAN)

University of Oxford

Status: Enrolling

Conditions: Cardiovascular Diseases; Cardiovascular Risk Factors

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05169333

The ORFAN Study

Details and patient eligibility

About

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.

Full description

The ORFAN registry will include unselected, consecutive patients undergoing CT scans (coronary CT angiograms (CCTA), CT chest, abdomen and pelvis scans) collected at the participating centres. The study will combine imaging data with patient demographics and clinical information (including prospective outcomes) to aid the development and/or validation of new or existing image analysis algorithms and software tools to improve diagnosis, clinical risk discrimination and prediction. Specifically, ORFAN will evaluate the specificity, utility and predictive value of newly developed image analysis methods. ORFAN will recruit and follow-up patients prospectively, linking the index CT scan with blood biomarkers, genetic information as well as information on disease progression (recorded through follow-up CT scans) and clinical outcomes data.

The study will also collect CT scans performed in the past and link them with clinical factors and prospective outcomes data collected after the index scan was performed.

Enrollment: 250,000 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

250,000 participants in 4 patient groups

Group 1

Description:

Participants attending cardiology department, hypertension or outpatient clinics.

Group 2

Description:

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

Description:

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

Description:

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.