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

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.
 
ClinicalTrials.gov Identifier: NCT01149590
Recruitment Status : Completed
First Posted : June 23, 2010
Last Update Posted : April 10, 2017
Sponsor:
Collaborators:
NHS Lothian
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
University of Edinburgh

Study Description
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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.

Condition or disease Intervention/treatment Phase
Angina Pectoris Coronary Heart Disease Procedure: Computer Tomography Angiography Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2010
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CT Calcium Score & Coronary Angiography
CT Scan
 Procedure: Computer Tomography Angiography
Computed Tomography Angiography
No Intervention: No CT Scan
No CT Scan


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients diagnosed with angina pectoris secondary to coronary heart disease [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Symptoms [ Time Frame: Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months ]
    (i) Chest pain. (ii) Quality of life.

  2. 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

  3. 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

  4. 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

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149590


Locations
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United Kingdom
Borders General Hospital
Melrose, Borders, United Kingdom, TD6 9BS
Victoria Hospital
Kirkcaldy, Fife, United Kingdom, KY2 5AH
Ninewells Hospital
Dundee, Tayside, United Kingdom, DD1 9SY
University Hospital Ayr
Ayr, United Kingdom, KA6 6DS
Royal Infirmary Edinburgh
Edinburgh, United Kingdom, EH16 4SB
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Western Infirmary Glasgow
Glasgow, United Kingdom, G11 6NT
Glasgow Royal Infirmary
Glasgow, United Kingdom, G31 2ER
Forth Valley Royal
Larbert, United Kingdom, FK5 4RW
St John's Hosptial
Livingston, United Kingdom, EH54 6PP
Royal Alexandra Hospital
Paisley, United Kingdom, PA2 9PN
Perth Royal Infirmary
Perth, United Kingdom, PH1 1NX
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Chief Scientist Office of the Scottish Government
Investigators
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Principal Investigator: David E Newby, BA BSc BM DM PhD FRCP DSc University of Edinburgh
More Information
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Publications:
Newby DE, Williams MC, Flapan AD, Forbes JF, Hargreaves AD, Leslie SJ, Lewis SC, McKillop G, McLean S, Reid JH, Sprat 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 SD, Ritchie V, Sudarshan T, Weir-McCall J, Cormack A, Findlay IN, Hood S, Murphy C, Peat E, Allen B, Baird A, Bertram D, Brian D, Cowan A, Cruden NL, Dweck MR, Flint L, Fyfe S, Keanie C, MacGillivray TJ, Maclachlan DS, MacLeod M, Mirsadraee S, Morrison A, Mills NL, Minns FC, Phillips A, Queripel LJ, Weir NW, Bett F, Divers F, Fairley K, Jacob AJ, Keegan E, White T, Gemmill J, Henry M, McGowan J, Dinnel L, Francis CM, Sandeman D, Yerramasu A, Berry C, Boylan H, Brown A, Duffy K, Frood A, Johnstone J, Lanaghan K, MacDuff R, MacLeod M, McGlynn D, McMillan N, Murdoch L, Noble C, Paterson V, Steedman T, Tzemos N. 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;13:184. doi: 10.1186/1745-6215-13-184.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01149590    
Other Study ID Numbers: CZH/4/588
First Posted: June 23, 2010    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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:
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Heart Diseases
Angina Pectoris
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
 Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Arteriosclerosis
Arterial Occlusive Diseases