Scottish COmputed Tomography of the HEART Trial (SCOT-HEART)
Primary Purpose
Angina Pectoris, Coronary Heart Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Computer Tomography Angiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Angina Pectoris focused on measuring Angina, Coronary Heart Disease, Computed Tomography, Angiogram, Coronary Artery Calcium Score, Chest Pain, Angina Pectoris due to Coronary Heart Disease
Eligibility 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
Sites / Locations
- Borders General Hospital
- Victoria Hospital
- Ninewells Hospital
- University Hospital Ayr
- Royal Infirmary Edinburgh
- Western General Hospital
- Western Infirmary Glasgow
- Glasgow Royal Infirmary
- Forth Valley Royal
- St John's Hosptial
- Royal Alexandra Hospital
- Perth Royal Infirmary
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CT Calcium Score & Coronary Angiography
No CT Scan
Arm Description
CT Scan
No CT Scan
Outcomes
Primary Outcome Measures
Proportion of patients diagnosed with angina pectoris secondary to coronary heart disease
Secondary Outcome Measures
Symptoms
(i) Chest pain. (ii) Quality of life.
Diagnosis
(i) Diagnosis and severity of coronary heart disease (ii) Accuracy of computed tomography coronary angiography
Investigations
(i) Exercise electrocardiographic stress test (ii) Nuclear medicine imaging - myocardial perfusion imaging (iii) Stress echocardiography (iv) Invasive coronary angiography (v) Non-coronary investigations
Treatment
(i) Secondary prevention (ii) Pharmacological anti-anginal therapy (iii) Coronary revascularisation
Long-term outcome
(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
Full Information
NCT ID
NCT01149590
First Posted
June 21, 2010
Last Updated
April 6, 2017
Sponsor
University of Edinburgh
Collaborators
NHS Lothian, Chief Scientist Office of the Scottish Government
1. Study Identification
Unique Protocol Identification Number
NCT01149590
Brief Title
Scottish COmputed Tomography of the HEART Trial
Acronym
SCOT-HEART
Official Title
Role of Multidetector Computed Tomography in the Diagnosis and Management of Patients Attending a Rapid Access Chest Pain Clinic
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
NHS Lothian, Chief Scientist Office of the Scottish Government
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT Calcium Score & Coronary Angiography
Arm Type
Experimental
Arm Description
CT Scan
Arm Title
No CT Scan
Arm Type
No Intervention
Arm Description
No CT Scan
Intervention Type
Procedure
Intervention Name(s)
Computer Tomography Angiography
Intervention Description
Computed Tomography Angiography
Primary Outcome Measure Information:
Title
Proportion of patients diagnosed with angina pectoris secondary to coronary heart disease
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Symptoms
Description
(i) Chest pain. (ii) Quality of life.
Time Frame
Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months
Title
Diagnosis
Description
(i) Diagnosis and severity of coronary heart disease (ii) Accuracy of computed tomography coronary angiography
Time Frame
Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months
Title
Investigations
Description
(i) Exercise electrocardiographic stress test (ii) Nuclear medicine imaging - myocardial perfusion imaging (iii) Stress echocardiography (iv) Invasive coronary angiography (v) Non-coronary investigations
Time Frame
Baseline, 6 weeks, 6 months
Title
Treatment
Description
(i) Secondary prevention (ii) Pharmacological anti-anginal therapy (iii) Coronary revascularisation
Time Frame
Baseline, after computed tomography scan (where appropriate), 6 weeks, 6 months
Title
Long-term outcome
Description
(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
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David E Newby, BA BSc BM DM PhD FRCP DSc
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Borders General Hospital
City
Melrose
State/Province
Borders
ZIP/Postal Code
TD6 9BS
Country
United Kingdom
Facility Name
Victoria Hospital
City
Kirkcaldy
State/Province
Fife
ZIP/Postal Code
KY2 5AH
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
State/Province
Tayside
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
University Hospital Ayr
City
Ayr
ZIP/Postal Code
KA6 6DS
Country
United Kingdom
Facility Name
Royal Infirmary Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SB
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Western Infirmary Glasgow
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Glasgow Royal Infirmary
City
Glasgow
ZIP/Postal Code
G31 2ER
Country
United Kingdom
Facility Name
Forth Valley Royal
City
Larbert
ZIP/Postal Code
FK5 4RW
Country
United Kingdom
Facility Name
St John's Hosptial
City
Livingston
ZIP/Postal Code
EH54 6PP
Country
United Kingdom
Facility Name
Royal Alexandra Hospital
City
Paisley
ZIP/Postal Code
PA2 9PN
Country
United Kingdom
Facility Name
Perth Royal Infirmary
City
Perth
ZIP/Postal Code
PH1 1NX
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
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Scottish COmputed Tomography of the HEART Trial
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