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

June 21, 2010
April 17, 2013
November 2010
April 2014   (final data collection date for primary outcome measure)
Proportion of patients diagnosed with angina pectoris secondary to coronary heart disease [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01149590 on ClinicalTrials.gov Archive Site
  • 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
  • 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 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
Not Provided
Not Provided
 
Scottish COmputed Tomography of the HEART Trial
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Angina Pectoris
  • Coronary Heart Disease
Procedure: Computer Tomography Angiography
Computed tomography imaging
  • Experimental: Computer Tomography Calcium Score and Coronary Angiography
    Intervention: Procedure: Computer Tomography Angiography
  • No Intervention: No CT Scan
    No CT Scan
Newby DE, Williams MC, Flappan AD, Forbes JF, Hargreaves AD, Leslie SJ, Lewis SC, McKillop G, McLean S, Reid J, Spratt JC, Uren NG, van Beek EJ, Boon NA, Clark L, Craig P, Flather MD, McCormack C, Roditi G, Timmis AD, Krishan A, Donaldson G, Fotheringham M, Hall FJ, Neary P, Cram L, Perkins S, Taylor F, Eteiba H, Rae AP, Robb K, Barrie D, Bissett K, Dawson A, Dundas S, Fogarty Y, Ramkumar PG, Houston GJ, Letham D, O'Neill L, Pringle S, Ritchie V, Sudarshan T, Weir-McCall J, Cormack A, Findlay IN, Hood S, Murphy C, Peat E, Allen B, Bertram D, Brian D, Cowan A, Cruden NL, Dweck MR, Flint L, Fyfe S, Harding C, Macgillivray TJ, Maclachlan DS, Macleod M, Misadraee S, Morrison A, Mills NL, Phillips A, Queripel LJ, Weir NW, Bett F, Divers F, Fairley K, Jacob AJ, Keegan E, White T, Gemmil J, Henry M, McGowan J, Dinnel L, Francis MC, Sandeman D, Yerramasu A, Morrison A, Berry C, Boylan H, Brown A, Duffy K, Frood A, Johnstone J, Langhan K, Macduff R, Macleod M, McGlynn D, McMillan N, Murdoch L, Noble C, Paterson V, Roditi G, Steedman T, Tzemos N, Baird A, Minns FC. Role of multidetector computed tomography in the diagnosis and management of patients attending the rapid access chest pain clinic, The Scottish computed tomography of the heart (SCOT-HEART) trial: study protocol for randomized controlled trial. Trials. 2012 Oct 4;13(1):184. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4138
January 2015
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Chiara McCormack, BSc, PhD +44 131 5373843 chiara.mccormack@ed.ac.uk
United Kingdom
 
NCT01149590
CZH/4/588
No
University of Edinburgh
University of Edinburgh
  • NHS Lothian
  • Chief Scientist Office of the Scottish Government
Principal Investigator: David E Newby, BA BSc BM DM PhD FRCP DSc University of Edinburgh
University of Edinburgh
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP