Coronary Artery Disease Clinical Trial
Official title:
A Pilot Clinical Trial of CT Coronary Angiography for Patients With Suspected Type 2 Myocardial Infarction
NCT number | NCT06047392 |
Other study ID # | GN22CA430 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 24, 2023 |
Est. completion date | February 2025 |
This study is to explore whether a computed tomography (CT) scan of the heart arteries might improve the care of patients that have presented with a suspected Type 2 myocardial infarction (MI). The Investigators hope to demonstrate that these patients may be the ideal group of patients to benefit from cardiac CT scan imaging by; 1. confirming whether they have any disease in their heart arteries 2. demonstrating the severity of the heart artery disease 3. revealing an alternative cause for their presentation 4. avoiding the need for an invasive heart artery angiogram.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | February 2025 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Patients with known or suspected Type 2 MI Exclusion Criteria: 1. Unable to provide written informed consent 2. Known severe coronary artery disease 3. Previous PCI 4. Previous CABG 5. Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2 6. Tachycardia (>75bpm) refractory to heart rate control 7. Pregnancy |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Queen Elizabeth University Hospital | Glasgow |
Lead Sponsor | Collaborator |
---|---|
NHS Greater Glasgow and Clyde | British Heart Foundation, University of Glasgow |
United Kingdom,
Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J Acute Cardiovasc Care. 2023 Sep 22:zuad107. doi: 10.1093/ehjacc/zuad107. Online ahead of print. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in primary diagnosis | The primary outcome is a change in the primary diagnosis defined as a difference in the final diagnosis at discharge compared to the initial diagnosis prior to study recruitment. The primary outcome will therefore take account of the diagnostic effect of CTCA and any changes that might normally occur during standard care. | At discharge from recruiting hospital (assessed up to day 30) | |
Secondary | Rate of invasive coronary angiography | Patients undergoing invasive coronary angiography following presentation | 3 months | |
Secondary | Major adverse cardiovascular events | Myocardial infarction, stroke or death | 12 months | |
Secondary | Rate of coronary revascularisation | Either percutaneous coronary intervention or coronary artery bypass grafting | 12 months | |
Secondary | Rate of hospital readmission | Readmission to hospital for any reason | 12 months | |
Secondary | Rate of additional cardiovascular investigations | Referral to outpatient clinic or for additional cardiovascular test (including exercise tolerance testing, echocardiography, myocardial perfusion imaging, cardiac MRI) | 12 months | |
Secondary | Health related quality of life assessment | EQ-5D-5L questionnaire. Reported as 5 digit code (Range 11111 - 55555) with higher numbers indicating worse quality of life and EQ visual analogue scale (Range 0-100) with higher numbers indicating better quality of life. | 6 months | |
Secondary | Functional assessment | Duke Activity Status Index (DASI). Range 0 - 58.2. Higher score indicates better functional status. | 6 months | |
Secondary | Estimated cost of health care | Health care resource utilisation including length of hospital stay, investigations and treatment | 12 months |
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