Scottish COmputed Tomography of the HEART Trial

Not Applicable

Completed

• Conditions: Coronary Heart Disease; Angina Pectoris
• Interventions: Procedure: Computer Tomography Angiography

• Registration Number: NCT01149590
• Lead Sponsor: University of Edinburgh

Brief Summary

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

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 Timeline

• Study First Submitted: 2010-06-21
• Study First Submitted QC: 2010-06-22
• Study First Posted: 2010-06-23
• Study Start: 2010-11
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2017-04
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT Calcium Score & Coronary Angiography	Computer Tomography Angiography	CT Scan

Primary Outcome Measures

Name	Time	Method
Proportion of patients diagnosed with angina pectoris secondary to coronary heart disease	6 weeks

Secondary Outcome Measures

Name	Time	Method
Symptoms	Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months	(i) Chest pain. (ii) Quality of life.
Investigations	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
Diagnosis	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
Treatment	Baseline, after computed tomography scan (where appropriate), 6 weeks, 6 months	(i) Secondary prevention (ii) Pharmacological anti-anginal therapy (iii) Coronary revascularisation
Long-term outcome	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

Trial Locations

Locations (12)

Victoria Hospital; 🇬🇧 Kirkcaldy, Fife, United Kingdom

Borders General Hospital; 🇬🇧 Melrose, Borders, United Kingdom

University Hospital Ayr; 🇬🇧 Ayr, United Kingdom

Royal Infirmary Edinburgh; 🇬🇧 Edinburgh, United Kingdom

Ninewells Hospital; 🇬🇧 Dundee, Tayside, United Kingdom

Western Infirmary Glasgow; 🇬🇧 Glasgow, United Kingdom

Western General Hospital; 🇬🇧 Edinburgh, United Kingdom

Glasgow Royal Infirmary; 🇬🇧 Glasgow, United Kingdom

St John's Hosptial; 🇬🇧 Livingston, United Kingdom

Forth Valley Royal; 🇬🇧 Larbert, United Kingdom

Perth Royal Infirmary; 🇬🇧 Perth, United Kingdom

Royal Alexandra Hospital; 🇬🇧 Paisley, United Kingdom