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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03920176

Recruitment Status Not yet recruiting

First Posted April 18, 2019

Last update posted September 25, 2019

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.

  • Condition or Disease:Cardiovascular Diseases
  • Intervention/Treatment: Other: ASSIGN Score
    Diagnostic Test: Computed tomography coronary angiography
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • 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 2020
  • Estimated Primary Completion Date: October 2023
  • Estimated Study Completion Date: April 2027
Arms and interventions
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
Outcome Measures
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 40 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 2 years.

Contacts and Locations
Contacts

Contact: David E Newby 01312426515 d.e.newby@ed.ac.uk

Contact: Trial Manager 0131 651 9901 scot.heart2@ed.ac.uk

Locations
Sponsors and Collaborators

University of Edinburgh

British Heart Foundation

NHS Lothian

Investigators

Principal Investigator: David E Newby University of Edinburgh

More Information
  • Responsible Party: University of Edinburgh
  • ClinicalTrials.gov Identifier: NCT03920176 History of Changes
  • 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.
  • 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: Cardiovascular Diseases
    Myocardial Infarction
    Infarction