Impact of TMAO Serum Levels on Hyperemic IMR in STEMI Patients
TAMIR
Impact of Trimethylamine N-oxide (TMAO) Serum Levels on Index of Microcirculatory Resistance (IMR) in Patients Diagnosed With ST-Elevation Myocardial Infarction (STEMI)
1 other identifier
observational
400
1 country
1
Brief Summary
Trimethylamine N-oxide (TMAO) is a gut microbiota-dependent metabolite of dietary choline, L-carnitine, and phosphatidylcholine-rich foods. On the basis of experimental studies and patients with prevalent disease, elevated plasma TMAO may increase risk of atherosclerotic cardiovascular disease (ASCVD). However, to our knowledge, no data is available on its impact on coronary microcirculation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 12, 2021
CompletedFirst Submitted
Initial submission to the registry
June 1, 2022
CompletedFirst Posted
Study publicly available on registry
June 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedAugust 16, 2022
August 1, 2022
1.5 years
June 1, 2022
August 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Index of microcirculatory resistance
The index of microcirculatory resistance (IMR) will be detected using PressureWire™ X Guidewire
3 months
Secondary Outcomes (2)
Left ventricular ejection fraction
3 months
major adverse cardiovascular events (MACE)
up to 1 year
Interventions
In brief, a 6-F angioplasty guiding catheter without side-holes will be used first used to engage the left main coronary artery. A pressure-temperature sensor guidewire ( PressureWire™ X Guidewire) will be used for physiology measurements including IMR measurements. Pressure measurement from the wire was first equalized with that of the guiding catheter. Then the pressure sensor will be positioned two-thirds of the way down the LAD artery. Intracoronary nitroglycerin will be administered (100 to 200 μg). Hyperemia will be induced with adenosine intracoronary injections.
Eligibility Criteria
This is a prospective, cohort study, conducted in the Hospital of the Lithuanian University of Health Sciences Kaunas Clinics.
You may qualify if:
- Patient diagnosed with STEMI
- Availability of non- left anterior descending artery (LAD) non culprit lesion, which is planned for a staged Percutaneous coronary intervention (PCI)
You may not qualify if:
- patient undergoing cardiopulmonary resuscitation;
- patients with a history of old myocardial infarction or history of coronary artery bypass grafting (CABG) or Percutaneous coronary intervention PCI
- Patients with signs of chronic infection, prolong usage of corticosteroids or compromised immune system
- patients had thrombolysis before primary Percutaneous coronary intervention (pPCI)
- had contraindication of adenosine triphosphate (ATP);
- had a history of liver or renal function dysfunction
- Patients with dementia
- Patients being referred to CABG after primary PCI
- unable to provide informed consent;
- had pregnancy or life span \< 1 year.
- Presence of sever structural valvular heart disease
- Presence of significant left main disease
- Unability to measure the index of microcirculatory resistance due to (death or retraction from the study ...etc)
- Inability to perform successful PCI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lithuanian University of Health Scienceslead
- Università degli Studi di Bresciacollaborator
- Kreiskrankenhaus Rotenburgcollaborator
Study Sites (1)
Ali Aldujeli
Kaunas, LT-50161, Lithuania
Related Publications (4)
Aldujeli A, Tsai TY, Haq A, Tatarunas V, Garg S, Hughes D, Ciapiene I, Unikas R, Sharif F, Lesauskaite V, Onuma Y, Serruys PW. The association between trimethylamine N-oxide levels and coronary microvascular dysfunction and prognosis in patients with ST-elevation myocardial infarction. Atherosclerosis. 2024 Nov;398:118597. doi: 10.1016/j.atherosclerosis.2024.118597. Epub 2024 Sep 12.
PMID: 39316928DERIVEDTsai TY, Aldujeli A, Haq A, Knokneris A, Briedis K, Hughes D, Unikas R, Renkens M, Revaiah PC, Tobe A, Miyashita K, Sharif F, Garg S, Onuma Y, Serruys PW. The Impact of Microvascular Resistance Reserve on the Outcome of Patients With STEMI. JACC Cardiovasc Interv. 2024 May 27;17(10):1214-1227. doi: 10.1016/j.jcin.2024.03.024. Epub 2024 May 14.
PMID: 38752970DERIVEDAldujeli A, Tsai TY, Haq A, Tatarunas V, Knokneris A, Briedis K, Unikas R, Onuma Y, Brilakis ES, Serruys PW. Impact of Coronary Microvascular Dysfunction on Functional Left Ventricular Remodeling and Diastolic Dysfunction. J Am Heart Assoc. 2024 May 7;13(9):e033596. doi: 10.1161/JAHA.123.033596. Epub 2024 Apr 30.
PMID: 38686863DERIVEDAldujeli A, Haq A, Tsai TY, Grabauskyte I, Tatarunas V, Briedis K, Rana S, Unikas R, Hamadeh A, Serruys PW, Brilakis ES. The impact of primary percutaneous coronary intervention strategies during ST-elevation myocardial infarction on the prevalence of coronary microvascular dysfunction. Sci Rep. 2023 Nov 16;13(1):20094. doi: 10.1038/s41598-023-47343-x.
PMID: 37973856DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cardiovascular disease consultant
Study Record Dates
First Submitted
June 1, 2022
First Posted
June 6, 2022
Study Start
January 12, 2021
Primary Completion
July 1, 2022
Study Completion
August 1, 2022
Last Updated
August 16, 2022
Record last verified: 2022-08