NCT03920176

Brief Summary

It is hypothesised that, in individuals being considered for cardiovascular preventative therapy, computed tomography coronary angiography guided management will reduce the future risk of coronary heart disease death or non-fatal myocardial infarction compared to management guided by the current standard of care, a cardiovascular risk score.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
6,139

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
32mo left

Started Jan 2020

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress70%
Jan 2020Dec 2028

First Submitted

Initial submission to the registry

April 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Expected
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

5.9 years

First QC Date

April 16, 2019

Last Update Submit

January 13, 2026

Conditions

Cardiovascular Diseases

Keywords

CardiologyComputed tomography coronary angiography

Outcome Measures

Primary Outcomes (1)

  • Coronary heart disease death or non-fatal myocardial infarction

    The primary research objective of the trial is to determine whether, in individuals with risk for cardiovascular disease, coronary heart disease screening with CTCA is associated with a reduction in the rate of coronary heart disease death or non-fatal myocardial infarction when compared to a probabilistic cardiovascular risk score approach.

    5 years

Secondary Outcomes (10)

  • Death

    5 Years

  • Cardiovascular Events

    5 Years

  • Cardiovascular Procedures

    5 Years

  • Quality of Life (EQ-5D-5L)

    2 Years

  • Prescription

    5 Years

  • +5 more secondary outcomes

Study Arms (2)

Computed tomography coronary angiography

ACTIVE COMPARATOR
Diagnostic Test: Computed tomography coronary angiography

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SHAM COMPARATOR
Other: ASSIGN Score

Interventions

Computed tomography coronary angiographyDIAGNOSTIC_TEST

CTCA \>64 detector row scanner

Computed tomography coronary angiography
ASSIGN ScoreOTHER

ASSIGN Cardiovascular Risk Score

Assign Score only

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥40 and ≤70 years of age
  • Resident in Scotland and have a Community Health Index (CHI) number
  • One or more of the following risk factors:
  • \>60 years of age
  • Current or recent (within 12 months) smoker
  • Clinical diagnosis of hypertension
  • Known hypercholesterolaemia or total cholesterol \>6.0 mmol/L or receiving statin therapy
  • Diabetes mellitus
  • Rheumatoid arthritis
  • Systemic lupus erythematosus (SLE)
  • Family history of premature cardiovascular disease (first degree relative with atherosclerotic cardiovascular disease below 60 years)
  • Chronic kidney disease stage 3 (estimate glomerular filtration rate 30-59 mL/min/1.73 m2).

You may not qualify if:

  • Inability to undergo CTCA
  • Known coronary heart disease or other major atherosclerotic cardiovascular disease
  • Prior invasive or non-invasive coronary angiography within the last 5 years
  • Chronic kidney disease stage ≥4 (estimate glomerular filtration rate \<30 mL/min/1.73 m2)
  • Known homozygous familial hypercholesterolaemia or other serious inherited disorders of lipid metabolism requiring statin therapy
  • Intolerance of all statins
  • Statin therapy for \>2 years.
  • Previous coronary artery imaging completed specifically for cardiovascular risk assessment with a result of \>10 AU.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western General Hospital

Edinburgh, City Of Edinburgh, EH4 2XU, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • David E Newby

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2019

First Posted

April 18, 2019

Study Start

January 13, 2020

Primary Completion

December 19, 2025

Study Completion (Estimated)

December 31, 2028

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The intention is to share anonymised data with external collaborators and scientists. The data will be available one year after the primary paper has been published (anticipated to be in 2027) .

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
After 2027.
Access Criteria
Requests can be made by email from 2027.

Locations

GB(1)