Scottish COmputed Tomography of the HEART Trial

University of Edinburgh4,138 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

4,138

Conditions

Angina Pectoris Coronary Heart Disease

Interventions

Computer Tomography AngiographyPROCEDURE

Computed Tomography Angiography

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (12)

Borders General Hospital

Melrose, Borders, United Kingdom

Victoria Hospital

Kirkcaldy, Fife, United Kingdom

Ninewells Hospital

Dundee, Tayside, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 6 weeks

Secondary Outcomes

Symptoms

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

Time frame: 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

Time frame: 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

Time frame: Baseline, 6 weeks, 6 months

Treatment

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

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

Long-term outcome

(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

Time frame: 10 years

Data from ClinicalTrials.gov

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