Non-invasive Coronary Thrombus Imaging to Define These Cause of Acute Myocardial Infarction

NCT06113510 | Recruiting DMC

• 1 other identifier: AC23119
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

We now have very sensitive blood tests that can pick up damage to the heart and find patients who have had a heart attack. However, whilst this is welcome, it does not identify what causes the heart attack and can sometimes pick up other conditions that cause a strain on the heart. The classic cause of a heart attack is when a blood clot forms on fatty deposits within the heart arteries. This leads to treating patients with blood thinning medication, and this is very effective and saves lives. However, many apparent heart attacks are not caused by blood clots and some may be caused by blood clots but pass unrecognised. In this proposal, we will test an exciting new imaging test that can 'see' from outside the body whether there is a blood clot in the heart arteries. This could provide a major new way of assessing patients to ensure they get the right diagnosis and the right treatment. This could ultimately improve the outcomes of or patients with heart attacks. We will recruit 80 patients in total who have recently been diagnosed with a heart attack from the cardiology department at the Royal Infirmary of Edinburgh. The research team will review patient's medical records to determine eligibility for the study. The research study involves participants undertaking the following research procedures and assessments:

1. 1.A combined Positron Emission Tomography and Computed Tomography (PET-CT) scan of the heart
2. 2.Ultrasound scan of the heart (Echocardiogram)
3. 3.MRI scan of the heart
4. 4.A blood test - a total of up to four tablespoons (60 mL) of blood will be taken for immediate testing and the remaining blood will be stored for future ethically approved studies
5. 5.A follow up questionnaire 6 -12 months following the heart attack

Conditions

Myocardial Infarction; Thrombosis

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will be the degree and location of platelet activation as determined by the target to background ratio of 18F-GP1

  3 years

Secondary Outcomes (1)

• The secondary endpoints will include measuring the presence of platelet activation in acute myocardial infarction with non-obstructive coronary arteries and identifying the presence and site of platelet activation in thrombosis-related coronary causes of

  3 years

Study Arms (2)

1

50 patients with myocardial infarction and non-obstructive coronary arteries

Radiation: Hybrid 18F-GP1 positron emission tomography and coronary computed tomography coronary angiography

2

10 patients with suspected coronary thromboembolism 10 patients with suspected spontaneous coronary artery dissection 10 patented with iatrogenic spontaneous coronary artery dissection

Radiation: Hybrid 18F-GP1 positron emission tomography and coronary computed tomography coronary angiography

Interventions

Hybrid 18F-GP1 positron emission tomography and coronary computed tomography coronary angiography RADIATION

18F-GP1 will be synthesized by our radiochemistry facility, the Edinburgh Imaging Facility Radiochemistry (EIFR), which is co-located within our Edinburgh Imaging Facility, Queens Medical Research Institute (EIF QMRI) using our well-established protocols. Each patient will undergo 18F-GP1 PET/CT coronary angiography imaging on our hybrid scanner (Biograph mCT, Siemens) as soon as practical after their index event and within a maximum of 7 days from symptom onset. Patients will initially be injected with 250 MBq 18F-GP1, before resting in a quiet environment for 60 min. A low-dose attenuation correction CT scan (120 kV, 50 mAs, 5/3 mm) will be followed by acquisition of PET data in list mode using a two 20-min bed position centred on the thoracic aorta and heart. A contrast-enhanced CT coronary angiogram will then be performed.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit two patient populations after invasive coronary angiography has been completed. We have established comparator control populations including 50 patients with stable coronary artery disease (no angina or recent myocardial infarction) and valvular heart disease who underwent 18F-GP1 cardiac PET-CT as part of a concurrent study (NCT04073875). Cohort 1: Patients with myocardial infarction with non-obstructive coronary arteries We will recruit 50 patients with myocardial infarction and non-obstructive coronary arteries on coronary angiography Cohort 2: Patients with coronary causes of type 2 myocardial infarction We will recruit 10 patients with coronary artery thromboembolism and 10 patients with spontaneous coronary artery dissection. Finally, we will include 10 subjects who have had iatrogenic coronary artery dissection or intramural haematoma as a complication of their percutaneous coronary intervention.

You may qualify if:

• Males and females ≥ 18 years of age
• Clinical presentation of chest pain, ST-segment deviation within a coronary artery territory on the electrocardiogram, raised cardiac troponin and non-obstructive coronary arteries on invasive coronary angiography as per international societal diagnostic criteria

You may not qualify if:

• \<18 years of age
• Takatsubo cardiomyopathy
• Myocarditis
• Renal failure (estimated glomerular filtration rate \<30 mL/min/1.73 m2)
• Woman of child-bearing potential who are pregnant or breastfeeding
• Known allergy or contraindication to iodinated contrast or radiotracer
• Patients unable to tolerate the supine position
• Patients unable to provide informed consent

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples (approximately 20mls)

MeSH Terms

Conditions

Myocardial Infarction; Thrombosis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Embolism and Thrombosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: January 6, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Resources and timescale: The project will run for 36 months. As principle investigator the majority of this period will involve the recruitment of patients, imaging acquisition and analysis and data analysis. Throughout the project, period publications will be generated with the main publications being generated towards the end of of the study.
• Access Criteria: Information will be disseminated internally to the cardiovascular research team through monthly departmental meetings. This will provide an opportunity to update on process, share knowledge with researchers who are also undertaking projects involving 18F-GP1 CT-PET. Communication on a wider scale will be through research publications.

Locations

GB (1)