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Completed

NCT Number: NCT01149590

Scottish COmputed Tomography of the HEART Trial

The primary objective of the study is to see if coronary artery calcium score and computed tomography coronary angiogram alters the proportion of patients diagnosed with angina due to coronary heart disease.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Borders General Hospital, Melrose, Borders, United Kingdom

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About this study

Rapid access chest pain clinics have facilitated the early diagnosis and treatment of patients with coronary heart disease and angina. Despite this important service provision, coronary heart disease continues to be under-diagnosed and many patients are left untreated and at risk. Recent advances in imaging technology have now led to the widespread use of non-invasive computed tomography both to measure coronary artery calcium scores and undertake coronary angiography. However, this technology has not been robustly evaluated in any systematic approach. Using state-of-the-art multidetector computed tomography scanners, we propose to undertake a major multicentre randomized controlled trial to assess the added value of computed tomography imaging in over 4000 patients attending rapid access chest pain clinics across Scotland. This will define the most appropriate use of this emerging technology in the setting of diagnosing and treating patients with coronary heart disease and angina pectoris. This study will also lay the foundation for future studies to look at the potential prognostic value of this technology.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 and ≤75 years of age
  • Attendance at the Rapid Access Chest Pain Clinic

Exclusion criteria

  • Inability or unwilling to undergo computed tomography scanning, such as exceeding weight tolerance of scanner
  • Severe renal failure (serum creatinine >200 µmol/L or estimated glomerular filtration rate <30 mL/min)
  • Previous recruitment to the trial
  • Major allergy to iodinated contrast agent
  • Unable to give informed consent
  • Known pregnancy
  • Acute coronary syndrome within 3 months

Treatment and study plan

Computer Tomography Angiography

Procedure

Computed Tomography Angiography

Primary outcomes

  1. Proportion of patients diagnosed with angina pectoris secondary to coronary heart disease

    Time frame: 6 weeks

Secondary outcomes

  1. Symptoms

    Time frame: Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months

    (i) Chest pain. (ii) Quality of life.

  2. Diagnosis

    Time frame: Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months

    (i) Diagnosis and severity of coronary heart disease (ii) Accuracy of computed tomography coronary angiography

  3. Investigations

    Time frame: Baseline, 6 weeks, 6 months

    (i) Exercise electrocardiographic stress test (ii) Nuclear medicine imaging - myocardial perfusion imaging (iii) Stress echocardiography (iv) Invasive coronary angiography (v) Non-coronary investigations

  4. Treatment

    Time frame: Baseline, after computed tomography scan (where appropriate), 6 weeks, 6 months

    (i) Secondary prevention (ii) Pharmacological anti-anginal therapy (iii) Coronary revascularisation

  5. Long-term outcome

    Time frame: 10 years

    (i) Coronary heart disease death or non-fatal Myocardial Infarction (MI) (ii) Coronary heart disease death (iii) Non-fatal MI (iv) Coronary heart disease death, non-fatal MI or non-fatal stroke (v) Non-fatal stroke (vi) All-cause death (vii) Cardiovascular death (viii) Coronary revascularisation; percutaneous coronary intervention or coronary artery bypass graft surgery (ix) Hospitalisation for chest pain including acute coronary syndromes and non-coronary chest pain (x) Hospitalisation for cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral arterial disease

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • Chief Scientist Office of the Scottish Government
  • NHS Lothian

Registry information

Official study title

Role of Multidetector Computed Tomography in the Diagnosis and Management of Patients Attending a Rapid Access Chest Pain Clinic

Acronym: SCOT-HEART

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jun 23, 2010
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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