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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University of Edinburgh
Sponsor:
Collaborators:
NHS Lothian
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01149590
First received: June 21, 2010
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Angina Pectoris
Coronary Heart Disease
Procedure: Computer Tomography Angiography

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Role of Multidetector Computed Tomography in the Diagnosis and Management of Patients Attending a Rapid Access Chest Pain Clinic

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Proportion of patients diagnosed with angina pectoris secondary to coronary heart disease [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptoms [ Time Frame: Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months ] [ Designated as safety issue: No ]
    (i) Chest pain. (ii) Quality of life.

  • Diagnosis [ Time Frame: Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months ] [ Designated as safety issue: No ]
    (i) Diagnosis and severity of coronary heart disease (ii) Accuracy of computed tomography coronary angiography

  • Investigations [ Time Frame: Baseline, 6 weeks, 6 months ] [ Designated as safety issue: No ]
    (i) Exercise electrocardiographic stress test (ii) Nuclear medicine imaging - myocardial perfusion imaging (iii) Stress echocardiography (iv) Invasive coronary angiography (v) Non-coronary investigations

  • Treatment [ Time Frame: Baseline, after computed tomography scan (where appropriate), 6 weeks, 6 months ] [ Designated as safety issue: No ]
    (i) Secondary prevention (ii) Pharmacological anti-anginal therapy (iii) Coronary revascularisation

  • Long-term outcome [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    (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


Estimated Enrollment: 4138
Study Start Date: November 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computer Tomography Calcium Score and Coronary Angiography Procedure: Computer Tomography Angiography
Computed tomography imaging
No Intervention: No CT Scan
No CT Scan

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01149590

Contacts
Contact: Chiara McCormack, BSc, PhD +44 131 5373843 chiara.mccormack@ed.ac.uk

Locations
United Kingdom
Borders General Hospital Recruiting
Melrose, Borders, United Kingdom, TD6 9BS
Contact: Chiara McCormack    0131 5373843    chiara.mccormack@ed.ac.uk   
Principal Investigator: Paul Neary         
Victoria Hospital Recruiting
Kirkcaldy, Fife, United Kingdom, KY2 5AH
Contact: Chiara McCormack    0131 5373843    chiara.mccormack@ed.ac.uk   
Principal Investigator: Mark Francis         
Ninewells Hospital Recruiting
Dundee, Tayside, United Kingdom, DD1 9SY
Contact: Chiara McCormack    0131 5373843    chiara.mccormack@ed.ac.uk   
Principal Investigator: Graeme Houston         
University Hospital Ayr Recruiting
Ayr, United Kingdom, KA6 6DS
Contact: Chiara McCormack    0131 5373843    chiara.mccormack@ed.ac.uk   
Principal Investigator: James McGowan         
Royal Infirmary Edinburgh Recruiting
Edinburgh, United Kingdom, EH16 4SB
Contact: Chiara McCormack, PhD    0131 5373843    chiara.mccormack@ed.ac.uk   
Principal Investigator: David E Newby, BA BSc BM DM PhD FRCP DSc         
Western General Hospital Recruiting
Edinburgh, United Kingdom, EH4 2XU
Contact: Chiara McCormack, PhD    0131 5373843    chiara.mccormack@ed.ac.uk   
Principal Investigator: David E Newby, BA BSc BM DM PhD FRCP DSc         
Western Infirmary Glasgow Recruiting
Glasgow, United Kingdom, G11 6NT
Contact: Chiara McCormack    01315373843    chiara.mccormack@ed.ac.uk   
Principal Investigator: Colin Berry         
Glasgow Royal Infirmary Recruiting
Glasgow, United Kingdom, G31 2ER
Contact: Chiara McCormack    0131 5373843    chiara.mccormack@ed.ac.uk   
Sub-Investigator: Hany Eteiba         
Forth Valley Royal Recruiting
Larbert, United Kingdom, FK5 4RW
Contact: Chiara McCormack    0131 5373843    chiara.mccormack@ed.ac.uk   
Principal Investigator: Allistair Hargreaves         
St John's Hosptial Recruiting
Livingston, United Kingdom, EH54 6PP
Contact: Chiara McCormack, PhD    0131 5373843    chiara.mccormack@ed.ac.uk   
Principal Investigator: David E Newby, BA BSc BM DM PhD FRCP DSc         
Royal Alexandra Hospital Recruiting
Paisley, United Kingdom, PA2 9PN
Contact: Chiara McCormack    01315373843    chiara.mccormack@ed.ac.uk   
Principal Investigator: Iain Findlay         
Perth Royal Infirmary Recruiting
Perth, United Kingdom, PH1 1NX
Contact: Chiara McCormack    0131 5373843    chiara.mccormack@ed.ac.uk   
Sub-Investigator: Hamish Dougall         
Sponsors and Collaborators
University of Edinburgh
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
  More Information

Publications:
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01149590     History of Changes
Other Study ID Numbers: CZH/4/588
Study First Received: June 21, 2010
Last Updated: April 17, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
Angina
Coronary Heart Disease
Computed Tomography
Angiogram
Coronary Artery Calcium Score
Chest Pain
Angina Pectoris due to Coronary Heart Disease

Additional relevant MeSH terms:
Angina Pectoris
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014