Scottish COmputed Tomography of the HEART Trial

NCT ID: NCT01149590

Last Updated: 2024-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2015-05-31

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.

Conditions

Angina Pectoris; Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CT Calcium Score & Coronary Angiography

CT Scan

Group Type: EXPERIMENTAL

Computer Tomography Angiography

Intervention Type: PROCEDURE

Computed Tomography Angiography

No CT Scan

No CT Scan

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Computer Tomography Angiography

Computed Tomography Angiography

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Lothian

OTHER_GOV

Sponsor Role: collaborator

Chief Scientist Office of the Scottish Government

OTHER_GOV

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David E Newby, BA BSc BM DM PhD FRCP DSc

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

Borders General Hospital

Melrose, Borders, United Kingdom

Victoria Hospital

Kirkcaldy, Fife, United Kingdom

Ninewells Hospital

Dundee, Tayside, United Kingdom

University Hospital Ayr

Ayr, , United Kingdom

Royal Infirmary Edinburgh

Edinburgh, , United Kingdom

Western General Hospital

Edinburgh, , United Kingdom

Western Infirmary Glasgow

Glasgow, , United Kingdom

Glasgow Royal Infirmary

Glasgow, , United Kingdom

Forth Valley Royal

Larbert, , United Kingdom

St John's Hosptial

Livingston, , United Kingdom

Royal Alexandra Hospital

Paisley, , United Kingdom

Perth Royal Infirmary

Perth, , United Kingdom

Countries

United Kingdom

References

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Other Identifiers

CZH/4/588

Identifier Type: -

Identifier Source: org_study_id