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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01149590
First Posted: June 23, 2010
Last Update Posted: April 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
NHS Lothian
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
University of Edinburgh
June 21, 2010
June 23, 2010
April 10, 2017
November 2010
May 2015   (Final data collection date for primary outcome measure)
Proportion of patients diagnosed with angina pectoris secondary to coronary heart disease [ Time Frame: 6 weeks ]
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 ]
    (i) Chest pain. (ii) Quality of life.
  • 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
  • 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
  • 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
  • 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
  • Symptoms [ Time Frame: Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months ]
    (i) Chest pain. (ii) Quality of life.
  • 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
  • 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
  • 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
  • Long-term outcome [ Time Frame: 10 years ]
    (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: None (Open Label)
Primary Purpose: Diagnostic
  • Angina Pectoris
  • Coronary Heart Disease
Procedure: Computer Tomography Angiography
Computed Tomography Angiography
  • Experimental: CT Calcium Score & Coronary Angiography
    CT Scan
    Intervention: Procedure: Computer Tomography Angiography
  • No Intervention: No CT Scan
    No CT Scan

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4138
May 2015
May 2015   (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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01149590
CZH/4/588
No
Not Provided
Plan to Share IPD: Undecided
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 2017

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