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Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (The SCOT-HEART 2 Trial) (SCOT-HEART 2)

Primary Purpose

Cardiovascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Computed tomography coronary angiography
ASSIGN Score
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases focused on measuring Cardiology, Computed tomography coronary angiography

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA

  • ≥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 (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).

EXCLUSION CRITERIA

  • 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.

Sites / Locations

  • Western General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Computed tomography coronary angiography

Assign Score only

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Death
Number of all-cause, cardiovascular, coronary heart disease and non-cardiovascular deaths
Cardiovascular Events
Number of participants who have fatal and non-fatal myocardial infarction or stroke
Cardiovascular Procedures
Number of Invasive coronary angiography and coronary revascularisation procedures
Quality of Life (EQ-5D-5L)
Quality of life measured using EQ-5D-5L instrument
Prescription
Rates of prescription of preventative therapies (anti-platelet, statin and angiotensin-converting enzyme inhibitor therapies)
Lifestyle Modification
Uptake of lifestyle modifications (smoking, exercise and diet) measured using self-reported questionnaire
Health Economics
Health economic assessment of cost-effectiveness
Cholesterol
Serum cholesterol concentration
Disadvantages of CTCA- Radiation
Radiation dose (mGy-cm)
Disadvantages of CTCA- incidental findings
Number of participants with incidental findings from CTCA

Full Information

First Posted
April 16, 2019
Last Updated
March 24, 2022
Sponsor
University of Edinburgh
Collaborators
British Heart Foundation, NHS Lothian
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1. Study Identification

Unique Protocol Identification Number
NCT03920176
Brief Title
Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (The SCOT-HEART 2 Trial)
Acronym
SCOT-HEART 2
Official Title
Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (The SCOT-HEART 2 Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
April 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
British Heart Foundation, NHS Lothian

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Prevention of cardiovascular disease is currently guided by probabilistic risk scores that both over and under treat individuals, commit most middle-aged people to pharmacotherapy, and have little evidence base. It has been demonstrated that use of computed tomography coronary angiography (CTCA) is associated with changes in the diagnosis and treatment of patients presenting with stable chest pain, and that this leads to a marked reduction in the future risk of myocardial infarction. Importantly, the proportionate reduction in coronary events was most marked in those with non-anginal chest pain irrespective of their cardiovascular risk score which again demonstrated poor discrimination. The research team propose a randomised controlled trial of at least 6,000 middle-aged individuals at risk of cardiovascular disease that will compare these two strategies of targeting preventative therapies: a probabilistic cardiovascular risk score, and screening with CTCA. This trial will determine if CTCA guided management will be associated with better targeted intervention, prevent over medicating the general population, and result in fewer future coronary heart disease events than the current standard of care using a cardiovascular risk score.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases
Keywords
Cardiology, Computed tomography coronary angiography

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
6000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Computed tomography coronary angiography
Arm Type
Active Comparator
Arm Title
Assign Score only
Arm Type
Sham Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Computed tomography coronary angiography
Intervention Description
CTCA >64 detector row scanner
Intervention Type
Other
Intervention Name(s)
ASSIGN Score
Intervention Description
ASSIGN Cardiovascular Risk Score
Primary Outcome Measure Information:
Title
Coronary heart disease death or non-fatal myocardial infarction
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Death
Description
Number of all-cause, cardiovascular, coronary heart disease and non-cardiovascular deaths
Time Frame
5 Years
Title
Cardiovascular Events
Description
Number of participants who have fatal and non-fatal myocardial infarction or stroke
Time Frame
5 Years
Title
Cardiovascular Procedures
Description
Number of Invasive coronary angiography and coronary revascularisation procedures
Time Frame
5 Years
Title
Quality of Life (EQ-5D-5L)
Description
Quality of life measured using EQ-5D-5L instrument
Time Frame
2 Years
Title
Prescription
Description
Rates of prescription of preventative therapies (anti-platelet, statin and angiotensin-converting enzyme inhibitor therapies)
Time Frame
5 Years
Title
Lifestyle Modification
Description
Uptake of lifestyle modifications (smoking, exercise and diet) measured using self-reported questionnaire
Time Frame
2 Years
Title
Health Economics
Description
Health economic assessment of cost-effectiveness
Time Frame
2 Years
Title
Cholesterol
Description
Serum cholesterol concentration
Time Frame
5 Years
Title
Disadvantages of CTCA- Radiation
Description
Radiation dose (mGy-cm)
Time Frame
5 Years
Title
Disadvantages of CTCA- incidental findings
Description
Number of participants with incidental findings from CTCA
Time Frame
5 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA ≥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 (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). EXCLUSION CRITERIA 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David E Newby
Phone
01312426515
Email
d.e.newby@ed.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Manager
Phone
0131 651 9901
Email
scot.heart2@ed.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David E Newby
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western General Hospital
City
Edinburgh
State/Province
City Of Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dave Newby
Email
d.e.newby@ed.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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) .
IPD Sharing Time Frame
After 2027.
IPD Sharing Access Criteria
Requests can be made by email from 2027.
Links:
URL
https://www.ed.ac.uk/usher/edinburgh-clinical-trials/our-studies/ukcrc-studies/scot-heart-2
Description
Study website

Learn more about this trial

Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (The SCOT-HEART 2 Trial)

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