The "MyoThrombus" Study

NCT04829825 | Completed

• 2 other identifiers: IRAS ID 255883E202276
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Left ventricular thrombus is a recognised complication of acute myocardial infarction, associated with stroke, recurrent myocardial infarction and adverse cardiac remodelling. The prevention, treatment and resolution of thrombus is hampered by a lack of understanding of its initiation, propagation and dissolution. Advanced non-invasive imaging holds major promise in improving our understanding of the incidence and the natural history of left ventricular thrombus as well as providing potential biomarkers to assess disease activity and treatment efficacy. In this prospective observational study, the investigators will recruit patients with recent acute anterior myocardial infarction and screen them for evidence of left ventricular thrombus and subclinical stroke using hybrid positron emission tomography and magnetic resonance imaging (PET/MR). Each patient will undergo PET/MR of the heart and head 7±2 days after acute myocardial infarction. If left ventricular thrombus is present on baseline MR, patients will be started on anticoagulation at the discretion of the attending physician, who will determine the agent used (warfarin or direct oral anticoagulant) and the duration of therapy (3-6 months). Patients will then undergo repeat PET/MR at completion of anti-coagulant therapy and then again after another 3 months. Patients with increased 18F- GP1 activity but no overt thrombus on MR will undergo repeat PET/MR of the head and heart at 3 and 6 months to establish the natural history of this observation and its association with thromboembolism in the brain. They will not routinely receive anticoagulation given the exploratory nature of this study.

Conditions

Left Ventricular Thrombus; Thrombosis; STEMI; Stroke

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will be platelet expression (active blood clot components) of the glycoprotein IIb/IIIa receptor in the heart and brain

  24 months

Secondary Outcomes (2)

• Time-course of left ventricular (heart muscle) platelet expression of the glycoprotein IIb/IIIa receptor following myocardial infarction (active blood clot).

  24 months

• Platelet expression (active blood clot components) of the glycoprotein IIb/IIIa receptor in other regions of the head (brain arteries) and thorax (coronary arteries - arteries of the heart).

  24 months

Interventions

18F-GP1 PET/MR DIAGNOSTIC_TEST

Patients will receive 1-3 18F-GP1 PET/MR

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 patients following anterior myocardial infarction.

You may qualify if:

• Male or females over the age of 40 with recent (within 21±2 days) acute type 1 anterior myocardial infarction
• Provision of informed consent prior to any study specific procedures

You may not qualify if:

• Inability or unwilling to give informed consent.
• Concomitant use of anticoagulation agents (warfarin, apixaban, edoxaban, rivaroxaban, dabigatran or SC/IV Heparin) (Cohort 1 only)
• Unable to tolerate the supine position
• Impaired renal function with eGFR of \<30 mL/min/1.73m2
• Severe or significant comorbidity
• Women who are pregnant or breastfeeding • Severe claustrophobia

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Royal Infirmary Edinburgh

Edinburgh, United Kingdom

Location

Related Publications (9)

• Wendelboe AM, Raskob GE. Global Burden of Thrombosis: Epidemiologic Aspects. Circ Res. 2016 Apr 29;118(9):1340-7. doi: 10.1161/CIRCRESAHA.115.306841.

  PMID: 27126645 BACKGROUND

• Jackson SP. The growing complexity of platelet aggregation. Blood. 2007 Jun 15;109(12):5087-95. doi: 10.1182/blood-2006-12-027698. Epub 2007 Feb 20.

  PMID: 17311994 BACKGROUND

• Turpie AG, Robinson JG, Doyle DJ, Mulji AS, Mishkel GJ, Sealey BJ, Cairns JA, Skingley L, Hirsh J, Gent M. Comparison of high-dose with low-dose subcutaneous heparin to prevent left ventricular mural thrombosis in patients with acute transmural anterior myocardial infarction. N Engl J Med. 1989 Feb 9;320(6):352-7. doi: 10.1056/NEJM198902093200604.

  PMID: 2643772 BACKGROUND

• Gianstefani S, Douiri A, Delithanasis I, Rogers T, Sen A, Kalra S, Charangwa L, Reiken J, Monaghan M, MacCarthy P. Incidence and predictors of early left ventricular thrombus after ST-elevation myocardial infarction in the contemporary era of primary percutaneous coronary intervention. Am J Cardiol. 2014 Apr 1;113(7):1111-6. doi: 10.1016/j.amjcard.2013.12.015. Epub 2014 Jan 14.

  PMID: 24485697 BACKGROUND

• Kalra A, Jang IK. Prevalence of early left ventricular thrombus after primary coronary intervention for acute myocardial infarction. J Thromb Thrombolysis. 2000 Oct;10(2):133-6. doi: 10.1023/a:1018710425817.

  PMID: 11005935 BACKGROUND

• Nayak D, Aronow WS, Sukhija R, McClung JA, Monsen CE, Belkin RN. Comparison of frequency of left ventricular thrombi in patients with anterior wall versus non-anterior wall acute myocardial infarction treated with antithrombotic and antiplatelet therapy with or without coronary revascularization. Am J Cardiol. 2004 Jun 15;93(12):1529-30. doi: 10.1016/j.amjcard.2004.02.066.

  PMID: 15194027 BACKGROUND

• Velangi PS, Choo C, Chen KA, Kazmirczak F, Nijjar PS, Farzaneh-Far A, Okasha O, Akcakaya M, Weinsaft JW, Shenoy C. Long-Term Embolic Outcomes After Detection of Left Ventricular Thrombus by Late Gadolinium Enhancement Cardiovascular Magnetic Resonance Imaging: A Matched Cohort Study. Circ Cardiovasc Imaging. 2019 Nov;12(11):e009723. doi: 10.1161/CIRCIMAGING.119.009723. Epub 2019 Nov 11.

  PMID: 31707810 BACKGROUND

• Andrews JPM, MacNaught G, Moss AJ, Doris MK, Pawade T, Adamson PD, van Beek EJR, Lucatelli C, Lassen ML, Robson PM, Fayad ZA, Kwiecinski J, Slomka PJ, Berman DS, Newby DE, Dweck MR. Cardiovascular 18F-fluoride positron emission tomography-magnetic resonance imaging: A comparison study. J Nucl Cardiol. 2021 Oct;28(5):1-12. doi: 10.1007/s12350-019-01962-y. Epub 2019 Dec 2.

  PMID: 31792913 BACKGROUND

• Lohrke J, Siebeneicher H, Berger M, Reinhardt M, Berndt M, Mueller A, Zerna M, Koglin N, Oden F, Bauser M, Friebe M, Dinkelborg LM, Huetter J, Stephens AW. 18F-GP1, a Novel PET Tracer Designed for High-Sensitivity, Low-Background Detection of Thrombi. J Nucl Med. 2017 Jul;58(7):1094-1099. doi: 10.2967/jnumed.116.188896. Epub 2017 Mar 16.

  PMID: 28302764 BACKGROUND

MeSH Terms

Conditions

Thrombosis; ST Elevation Myocardial Infarction; Stroke

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

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

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 2, 2021
• Study Start: January 2, 2020
• Primary Completion: February 19, 2026
• Study Completion: February 19, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)