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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03920176
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborators:
British Heart Foundation
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Diagnostic Test: Computed tomography coronary angiography Other: ASSIGN Score Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (The SCOT-HEART 2 Trial)
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : April 1, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Computed tomography coronary angiography Diagnostic Test: Computed tomography coronary angiography
CTCA >64 detector row scanner

Other: ASSIGN Score
ASSIGN Cardiovascular Risk Score

Sham Comparator: Assign Score only Other: ASSIGN Score
ASSIGN Cardiovascular Risk Score




Primary Outcome Measures :
  1. Coronary heart disease death or non-fatal myocardial infarction [ Time Frame: 5 years ]
    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 :
  1. Death [ Time Frame: 5 Years ]
    Number of all-cause, cardiovascular, coronary heart disease and non-cardiovascular deaths

  2. Cardiovascular Events [ Time Frame: 5 Years ]
    Number of participants who have fatal and non-fatal myocardial infarction or stroke

  3. Cardiovascular Procedures [ Time Frame: 5 Years ]
    Number of Invasive coronary angiography and coronary revascularisation procedures

  4. Quality of Life (EQ-5D-5L) [ Time Frame: 2 Years ]
    Quality of life measured using EQ-5D-5L instrument

  5. Prescription [ Time Frame: 5 Years ]
    Rates of prescription of preventative therapies (anti-platelet, statin and angiotensin-converting enzyme inhibitor therapies)

  6. Lifestyle Modification [ Time Frame: 2 Years ]
    Uptake of lifestyle modifications (smoking, exercise and diet) measured using self-reported questionnaire

  7. Health Economics [ Time Frame: 2 Years ]
    Health economic assessment of cost-effectiveness

  8. Cholesterol [ Time Frame: 5 Years ]
    Serum cholesterol concentration

  9. Disadvantages of CTCA- Radiation [ Time Frame: 5 Years ]
    Radiation dose (mGy-cm)

  10. Disadvantages of CTCA- incidental findings [ Time Frame: 5 Years ]
    Number of participants with incidental findings from CTCA



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920176


Contacts
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Contact: David E Newby 01312426515 d.e.newby@ed.ac.uk
Contact: Trial Manager 0131 651 9901 scot.heart2@ed.ac.uk

Sponsors and Collaborators
University of Edinburgh
British Heart Foundation
NHS Lothian
Investigators
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Principal Investigator: David E Newby University of Edinburgh
Additional Information:
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03920176    
Other Study ID Numbers: IRAS ID: 261185
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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) .
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: After 2027.
Access Criteria: Requests can be made by email from 2027.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Edinburgh:
Cardiology
Computed tomography coronary angiography
Additional relevant MeSH terms:
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Cardiovascular Diseases
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Vascular Diseases