Scottish COmputed Tomography of the HEART Trial (SCOT-HEART)
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| ClinicalTrials.gov Identifier: NCT01149590 |
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Recruitment Status :
Completed
First Posted : June 23, 2010
Last Update Posted : April 10, 2017
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Sponsor:
University of Edinburgh
Collaborators:
NHS Lothian
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
University of Edinburgh
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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 |
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 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
| Arm | Intervention/treatment |
|---|---|
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Experimental: CT Calcium Score & Coronary Angiography
CT Scan
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Procedure: Computer Tomography Angiography
Computed Tomography Angiography |
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No Intervention: No CT Scan
No CT Scan
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Primary Outcome Measures :
- Proportion of patients diagnosed with angina pectoris secondary to coronary heart disease [ Time Frame: 6 weeks ]
Secondary Outcome Measures :
- 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
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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
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
| 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
| Principal Investigator: | David E Newby, BA BSc BM DM PhD FRCP DSc | University of Edinburgh |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
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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 |