Scottish COmputed Tomography of the HEART Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Angina Pectoris, Coronary Heart Disease

Intervention / Treatment
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* Procedure: Computer Tomography Angiography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT Calcium Score & Coronary Angiography<br>CT Scan | Procedure: Computer Tomography Angiography<br>* Computed Tomography Angiography<br>|
| No Intervention: No CT Scan<br>No CT Scan | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients diagnosed with angina pectoris secondary to coronary heart disease |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms | (i) Chest pain. (ii) Quality of life. | Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months | 
| Diagnosis | (i) Diagnosis and severity of coronary heart disease (ii) Accuracy of computed tomography coronary angiography | Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months | 
| Investigations | (i) Exercise electrocardiographic stress test (ii) Nuclear medicine imaging - myocardial perfusion imaging (iii) Stress echocardiography (iv) Invasive coronary angiography (v) Non-coronary investigations | Baseline, 6 weeks, 6 months | 
| Treatment | (i) Secondary prevention (ii) Pharmacological anti-anginal therapy (iii) Coronary revascularisation | Baseline, after computed tomography scan (where appropriate), 6 weeks, 6 months | 
| Long-term outcome | (i) Cardiovascular death or non-fatal Myocardial Infarction (MI) (ii) Cardiovascular death (iii) Non-fatal MI (iv) Cardiovascular death, non-fatal MI or non-fatal stroke (v) Non-fatal stroke (vi) All-cause death (vii) Coronary revascularisation; percutaneous coronary intervention or coronary artery bypass graft surgery (viii) Hospitalisation for chest pain including acute coronary syndromes and non-coronary chest pain (ix) Hospitalisation for cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral arterial disease | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angina, Coronary Heart Disease, Computed Tomography, Angiogram, Coronary Artery Calcium Score, Chest Pain, Angina Pectoris due to Coronary Heart Disease