SECURE Trial: Stress Echocardiography With Carotid Ultrasound vs Routine CT Coronary Angiography in Chronic Coronary Syndrome for Endpoints

Launched by LONDON NORTH WEST HEALTHCARE NHS TRUST · Dec 14, 2023

Keywords

ClinConnect Summary

The SECURE Trial is studying two different tests for patients with chronic coronary syndrome (a type of heart disease) to see which one gives better information about the condition. The tests being compared are Computed Tomography Coronary Angiography (CTCA), which uses a special type of X-ray to look at the blood vessels of the heart, and Stress Echocardiography combined with Carotid Ultrasound, which uses sound waves to see how well blood flows to the heart and also checks the neck arteries. The goal is to find out if combining these tests can help doctors identify both severe and less severe heart issues more effectively, leading to better treatment options for patients.

To be eligible for the trial, participants need to be at least 18 years old and have symptoms or risk factors suggesting they might have coronary artery disease (CAD). This could include chest pain or other related symptoms. The study will enroll about 2,000 people, and those who participate will be randomly assigned to one of the two tests. They'll be followed for five years to see how they do and will also fill out some questionnaires about their health. This trial is important because it could lead to a new way of testing for heart disease that is more comprehensive and helpful for patients.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age \> 18 years old
• • 2. Patients referred to RACPC and judged by the reviewer to require a further imaging investigation, either SE or CTCA, to evaluate a suspected diagnosis of CAD
• • 3. AND
• • 1. Have a PTP score ≥ 5%, as calculated using ESC guidelines OR
• • 2. Have clinical history in keeping with 'typical' angina symptoms, as judged by the investigator, in patients with a PTP score \<5% - With 'typical' symptoms, as per ESC guidelines, being all three of the following
• • i) Constricting symptoms in the front of the chest or in the neck, jaw, shoulder or arm ii) Precipitated by physical exertion iii) Relieved by rest or nitrates within 5 minutes
• • 4. Able to give informed consent to participate in the study and its follow up
• Exclusion Criteria:
• • 1. Patients with diagnosed ACS that require urgent or emergency treatment or hospitalisation for inpatient investigations.
• • 2. Known history of obstructive CAD (Previous MI, PCI or CABG) or previous invasive angiography with evidence of ≥ 50% stenosis in any epicardial vessel.
• • 3. Patients who have undergone invasive or non-invasive, functional or anatomical (Including CAC score) testing for detection of CAD within the previous 1 year of clinical assessment.
• • 4. Documented allergy to iodinated contrast or documented allergy to both ultrasound contrasts used at LNWH Trust; Luminity® (Perflutren) and SonoVue® (Sulphur Hexafluoride) or the constitutes
• • 5. Contraindications to undergoing CTCA, including but not limited to;
• • eGFR \< 40 ml/min
• • Contraindications to beta-blockers including but not limited to, documented allergy or significant airways disease in the judgement of the investigator.
• • Exceeding CT scanner weight tolerance
• • 6. Contraindications to undergoing SE, including but not limited to;
• • Known cardiomyopathic process (Hypertrophic cardiomyopathy (HCM)) with resting gradient \> 50mmHg or severe valvular lesion
• • Severe uncontrolled hypertension (≥180/100mmHg)
• • 7. Known pregnancy
• • 8. Unable to provide informed consent