Scottish COmputed Tomography of the HEART Trial

NCT01149590 | Completed

• 1 other identifier: CZH/4/588
• Study Type: interventional
• Target: 4,138
• Locations: 1 country
• Sites: 12

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.

Conditions

Angina Pectoris; Coronary Heart Disease

Keywords

Angina; Coronary Heart Disease; Computed Tomography; Angiogram; Coronary Artery Calcium Score; Chest Pain; Angina Pectoris due to Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of patients diagnosed with angina pectoris secondary to coronary heart disease

  6 weeks

Secondary Outcomes (5)

• Symptoms

  Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months

• Diagnosis

  Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months

• Investigations

  Baseline, 6 weeks, 6 months

• Treatment

  Baseline, after computed tomography scan (where appropriate), 6 weeks, 6 months

• Long-term outcome

  10 years

Study Arms (2)

CT Calcium Score & Coronary Angiography

EXPERIMENTAL

CT Scan

Procedure: Computer Tomography Angiography

No CT Scan

NO INTERVENTION

No CT Scan

Interventions

Computer Tomography Angiography PROCEDURE

Computed Tomography Angiography

CT Calcium Score & Coronary Angiography

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• and ≤75 years of age
• Attendance at the Rapid Access Chest Pain Clinic

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator
• Chief Scientist Office of the Scottish Government: collaborator

Study Sites (12)

Borders General Hospital

Melrose, Borders, TD6 9BS, United Kingdom

Location

Victoria Hospital

Kirkcaldy, Fife, KY2 5AH, United Kingdom

Location

Ninewells Hospital

Dundee, Tayside, DD1 9SY, United Kingdom

Location

University Hospital Ayr

Ayr, KA6 6DS, United Kingdom

Location

Royal Infirmary Edinburgh

Edinburgh, EH16 4SB, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Western Infirmary Glasgow

Glasgow, G11 6NT, United Kingdom

Location

Glasgow Royal Infirmary

Glasgow, G31 2ER, United Kingdom

Location

Forth Valley Royal

Larbert, FK5 4RW, United Kingdom

Location

St John's Hosptial

Livingston, EH54 6PP, United Kingdom

Location

Royal Alexandra Hospital

Paisley, PA2 9PN, United Kingdom

Location

Perth Royal Infirmary

Perth, PH1 1NX, United Kingdom

Location

Related Publications (20)

• 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.

  PMID: 23036114 BACKGROUND

• SCOT-HEART investigators. CT coronary angiography in patients with suspected angina due to coronary heart disease (SCOT-HEART): an open-label, parallel-group, multicentre trial. Lancet. 2015 Jun 13;385(9985):2383-91. doi: 10.1016/S0140-6736(15)60291-4. Epub 2015 Mar 15.

  PMID: 25788230 RESULT

• SCOT-HEART Investigators; Newby DE, Adamson PD, Berry C, Boon NA, Dweck MR, Flather M, Forbes J, Hunter A, Lewis S, MacLean S, Mills NL, Norrie J, Roditi G, Shah ASV, Timmis AD, van Beek EJR, Williams MC. Coronary CT Angiography and 5-Year Risk of Myocardial Infarction. N Engl J Med. 2018 Sep 6;379(10):924-933. doi: 10.1056/NEJMoa1805971. Epub 2018 Aug 25.

  PMID: 30145934 RESULT

• Rasmussen LD, Sikjaer M, Soby JH, Pedersen OB, Westra J, Efthekhari A, Christiansen EH, Foldyna B, Williams MC, Dweck MR, Newby DE, Douglas PS, Bottcher M, Winther S. Dual probability approach for risk adjustment in patients with a low clinical likelihood of coronary artery disease. Eur Heart J Cardiovasc Imaging. 2025 Aug 29;26(9):1507-1517. doi: 10.1093/ehjci/jeaf193.

  PMID: 40590244 DERIVED

• Williams MC, Wereski R, Tuck C, Adamson PD, Shah ASV, van Beek EJR, Roditi G, Berry C, Boon N, Flather M, Lewis S, Norrie J, Timmis AD, Mills NL, Dweck MR, Newby DE; SCOT-HEART Investigators. Coronary CT angiography-guided management of patients with stable chest pain: 10-year outcomes from the SCOT-HEART randomised controlled trial in Scotland. Lancet. 2025 Jan 25;405(10475):329-337. doi: 10.1016/S0140-6736(24)02679-5.

  PMID: 39863372 DERIVED

• Kolossvary M, Lin A, Kwiecinski J, Cadet S, Slomka PJ, Newby DE, Dweck MR, Williams MC, Dey D. Coronary Plaque Radiomic Phenotypes Predict Fatal or Nonfatal Myocardial Infarction: Analysis of the SCOT-HEART Trial. JACC Cardiovasc Imaging. 2025 Mar;18(3):308-319. doi: 10.1016/j.jcmg.2024.08.012. Epub 2024 Oct 30.

  PMID: 39480364 DERIVED

• Williams MC, Kwiecinski J, Doris M, McElhinney P, D'Souza MS, Cadet S, Adamson PD, Moss AJ, Alam S, Hunter A, Shah ASV, Mills NL, Pawade T, Wang C, Weir-McCall JR, Bonnici-Mallia M, Murrills C, Roditi G, van Beek EJR, Shaw LJ, Nicol ED, Berman DS, Slomka PJ, Newby DE, Dweck MR, Dey D. Sex-Specific Computed Tomography Coronary Plaque Characterization and Risk of Myocardial Infarction. JACC Cardiovasc Imaging. 2021 Sep;14(9):1804-1814. doi: 10.1016/j.jcmg.2021.03.004. Epub 2021 Apr 14.

  PMID: 33865779 DERIVED

• Singh T, Bing R, Dweck MR, van Beek EJR, Mills NL, Williams MC, Villines TC, Newby DE, Adamson PD. Exercise Electrocardiography and Computed Tomography Coronary Angiography for Patients With Suspected Stable Angina Pectoris: A Post Hoc Analysis of the Randomized SCOT-HEART Trial. JAMA Cardiol. 2020 Aug 1;5(8):920-928. doi: 10.1001/jamacardio.2020.1567.

  PMID: 32492104 DERIVED

• Williams MC, Kwiecinski J, Doris M, McElhinney P, D'Souza MS, Cadet S, Adamson PD, Moss AJ, Alam S, Hunter A, Shah ASV, Mills NL, Pawade T, Wang C, Weir McCall J, Bonnici-Mallia M, Murrills C, Roditi G, van Beek EJR, Shaw LJ, Nicol ED, Berman DS, Slomka PJ, Newby DE, Dweck MR, Dey D. Low-Attenuation Noncalcified Plaque on Coronary Computed Tomography Angiography Predicts Myocardial Infarction: Results From the Multicenter SCOT-HEART Trial (Scottish Computed Tomography of the HEART). Circulation. 2020 May 5;141(18):1452-1462. doi: 10.1161/CIRCULATIONAHA.119.044720. Epub 2020 Mar 16.

  PMID: 32174130 DERIVED

• Adamson PD, Williams MC, Dweck MR, Mills NL, Boon NA, Daghem M, Bing R, Moss AJ, Mangion K, Flather M, Forbes J, Hunter A, Norrie J, Shah ASV, Timmis AD, van Beek EJR, Ahmadi AA, Leipsic J, Narula J, Newby DE, Roditi G, McAllister DA, Berry C; SCOT-HEART Investigators. Guiding Therapy by Coronary CT Angiography Improves Outcomes in Patients With Stable Chest Pain. J Am Coll Cardiol. 2019 Oct 22;74(16):2058-2070. doi: 10.1016/j.jacc.2019.07.085.

  PMID: 31623764 DERIVED

• Bing R, Henderson J, Hunter A, Williams MC, Moss AJ, Shah ASV, McAllister DA, Dweck MR, Newby DE, Mills NL, Adamson PD. Clinical determinants of plasma cardiac biomarkers in patients with stable chest pain. Heart. 2019 Nov;105(22):1748-1754. doi: 10.1136/heartjnl-2019-314892. Epub 2019 Jun 1.

  PMID: 31154425 DERIVED

• Williams MC, Moss AJ, Dweck M, Adamson PD, Alam S, Hunter A, Shah ASV, Pawade T, Weir-McCall JR, Roditi G, van Beek EJR, Newby DE, Nicol ED. Coronary Artery Plaque Characteristics Associated With Adverse Outcomes in the SCOT-HEART Study. J Am Coll Cardiol. 2019 Jan 29;73(3):291-301. doi: 10.1016/j.jacc.2018.10.066.

  PMID: 30678759 DERIVED

• Adamson PD, Hunter A, Madsen DM, Shah ASV, McAllister DA, Pawade TA, Williams MC, Berry C, Boon NA, Flather M, Forbes J, McLean S, Roditi G, Timmis AD, van Beek EJR, Dweck MR, Mickley H, Mills NL, Newby DE. High-Sensitivity Cardiac Troponin I and the Diagnosis of Coronary Artery Disease in Patients With Suspected Angina Pectoris. Circ Cardiovasc Qual Outcomes. 2018 Feb;11(2):e004227. doi: 10.1161/CIRCOUTCOMES.117.004227.

  PMID: 29444926 DERIVED

• Adamson PD, Fordyce CB, McAllister DA, Udelson JE, Douglas PS, Newby DE. Identification of patients with stable chest pain deriving minimal value from coronary computed tomography angiography: An external validation of the PROMISE minimal-risk tool. Int J Cardiol. 2018 Feb 1;252:31-34. doi: 10.1016/j.ijcard.2017.09.033.

  PMID: 29249436 DERIVED

• Adamson PD, Hunter A, Williams MC, Shah ASV, McAllister DA, Pawade TA, Dweck MR, Mills NL, Berry C, Boon NA, Clark E, Flather M, Forbes J, McLean S, Roditi G, van Beek EJR, Timmis AD, Newby DE. Diagnostic and prognostic benefits of computed tomography coronary angiography using the 2016 National Institute for Health and Care Excellence guidance within a randomised trial. Heart. 2018 Feb;104(3):207-214. doi: 10.1136/heartjnl-2017-311508. Epub 2017 Aug 27.

  PMID: 28844992 DERIVED

• McCarter RV, McKay GJ, Quinn NB, Chakravarthy U, MacGillivray TJ, Robertson G, Pellegrini E, Trucco E, Williams MC, Peto T, Dhillon B, van Beek EJ, Newby DE, Kee F, Young IS, Hogg RE. Evaluation of coronary artery disease as a risk factor for reticular pseudodrusen. Br J Ophthalmol. 2018 Apr;102(4):483-489. doi: 10.1136/bjophthalmol-2017-310526. Epub 2017 Aug 19.

  PMID: 28822985 DERIVED

• Williams MC, Hunter A, Shah A, Assi V, Lewis S, Mangion K, Berry C, Boon NA, Clark E, Flather M, Forbes J, McLean S, Roditi G, van Beek EJ, Timmis AD, Newby DE; Scottish COmputed Tomography of the HEART (SCOT-HEART) Trial Investigators. Symptoms and quality of life in patients with suspected angina undergoing CT coronary angiography: a randomised controlled trial. Heart. 2017 Jul;103(13):995-1001. doi: 10.1136/heartjnl-2016-310129. Epub 2017 Feb 28.

  PMID: 28246175 DERIVED

• Williams MC, Hunter A, Shah ASV, Assi V, Lewis S, Smith J, Berry C, Boon NA, Clark E, Flather M, Forbes J, McLean S, Roditi G, van Beek EJR, Timmis AD, Newby DE; SCOT-HEART Investigators. Use of Coronary Computed Tomographic Angiography to Guide Management of Patients With Coronary Disease. J Am Coll Cardiol. 2016 Apr 19;67(15):1759-1768. doi: 10.1016/j.jacc.2016.02.026.

  PMID: 27081014 DERIVED

• Moss AJ, Newby DE. CT coronary angiographic evaluation of suspected anginal chest pain. Heart. 2016 Feb 15;102(4):263-8. doi: 10.1136/heartjnl-2015-307860. Epub 2015 Dec 8.

  PMID: 26647079 DERIVED

• Williams MC, Golay SK, Hunter A, Weir-McCall JR, Mlynska L, Dweck MR, Uren NG, Reid JH, Lewis SC, Berry C, van Beek EJ, Roditi G, Newby DE, Mirsadraee S. Observer variability in the assessment of CT coronary angiography and coronary artery calcium score: substudy of the Scottish COmputed Tomography of the HEART (SCOT-HEART) trial. Open Heart. 2015 May 19;2(1):e000234. doi: 10.1136/openhrt-2014-000234. eCollection 2015.

  PMID: 26019881 DERIVED

MeSH Terms

Conditions

Angina Pectoris; Coronary Disease; Chest Pain

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David E Newby, BA BSc BM DM PhD FRCP DSc

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: June 23, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 3, 2024

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Post primary publication

Locations

GB (12)