Scottish COmputed Tomography of the HEART Trial (SCOT-HEART)

April 6, 2017 updated by: University of Edinburgh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Ayr, United Kingdom, KA6 6DS
        • University Hospital Ayr
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital
      • Edinburgh, United Kingdom, EH16 4SB
        • Royal Infirmary Edinburgh
      • Glasgow, United Kingdom, G31 2ER
        • Glasgow Royal Infirmary
      • Glasgow, United Kingdom, G11 6NT
        • Western Infirmary Glasgow
      • Larbert, United Kingdom, FK5 4RW
        • Forth Valley Royal
      • Livingston, United Kingdom, EH54 6PP
        • St John's Hosptial
      • Paisley, United Kingdom, PA2 9PN
        • Royal Alexandra Hospital
      • Perth, United Kingdom, PH1 1NX
        • Perth Royal Infirmary
    • Borders
      • Melrose, Borders, United Kingdom, TD6 9BS
        • Borders General Hospital
    • Fife
      • Kirkcaldy, Fife, United Kingdom, KY2 5AH
        • Victoria Hospital
    • Tayside
      • Dundee, Tayside, United Kingdom, DD1 9SY
        • Ninewells Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CT Calcium Score & Coronary Angiography
CT Scan
Procedure: Computer Tomography Angiography
Computed Tomography Angiography
No Intervention: No CT Scan

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms
Time Frame: Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months
(i) Chest pain. (ii) Quality of life.
Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months
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
Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months
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
Baseline, 6 weeks, 6 months
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
Baseline, after computed tomography scan (where appropriate), 6 weeks, 6 months
Long-term outcome
Time Frame: 10 years
(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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

NHS Lothian
Chief Scientist Office of the Scottish Government

Investigators

  • Principal Investigator: David E Newby, BA BSc BM DM PhD FRCP DSc, University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

June 21, 2010

First Submitted That Met QC Criteria

June 22, 2010

First Posted (Estimate)

June 23, 2010

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZH/4/588

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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