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Impact of TMAO Serum Levels on Hyperemic IMR in STEMI Patients

Impact of Trimethylamine N-oxide (TMAO) Serum Levels on Index of Microcirculatory Resistance (IMR) in Patients Diagnosed With ST-Elevation Myocardial Infarction (STEMI)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05406297
Acronym
TAMIR
Enrollment
400
Registered
2022-06-06
Start date
2021-01-12
Completion date
2022-08-01
Last updated
2022-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microvascular Coronary Artery Disease, STEMI - ST Elevation Myocardial Infarction

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.

Interventions

PROCEDUREpressure-temperature sensor guidewire-based measurement

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.

Sponsors

Università degli Studi di Brescia
CollaboratorOTHER
Kreiskrankenhaus Rotenburg
CollaboratorUNKNOWN
Lithuanian University of Health Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum

Inclusion criteria

1. Patient diagnosed with STEMI 2. Availability of non- left anterior descending artery (LAD) non culprit lesion, which is planned for a staged Percutaneous coronary intervention (PCI)

Exclusion criteria

1. patient undergoing cardiopulmonary resuscitation; 2. patients with a history of old myocardial infarction or history of coronary artery bypass grafting (CABG) or Percutaneous coronary intervention PCI 3. Patients with signs of chronic infection, prolong usage of corticosteroids or compromised immune system 4. patients had thrombolysis before primary Percutaneous coronary intervention (pPCI) 5. had contraindication of adenosine triphosphate (ATP); 6. had a history of liver or renal function dysfunction 7. Patients with dementia 8. Patients being referred to CABG after primary PCI 9. unable to provide informed consent; 10. had pregnancy or life span \< 1 year. 11. Presence of sever structural valvular heart disease 12. Presence of significant left main disease 13. Unability to measure the index of microcirculatory resistance due to (death or retraction from the study ...etc) 14. Inability to perform successful PCI

Design outcomes

Primary

MeasureTime frameDescription
Index of microcirculatory resistance3 monthsThe index of microcirculatory resistance (IMR) will be detected using PressureWire™ X Guidewire

Secondary

MeasureTime frameDescription
Left ventricular ejection fraction3 monthsleft ventricular ejection fraction will be assessed via echocardiography imaging using Simpson's biplane method.
major adverse cardiovascular events (MACE)up to 1 year. MACE was defined as follows: cardiovascular death, non-fatal myocardial infarction, target vessel revascularization, recurrent hospitalization due to decompensated heart failure, and stroke (ischemic or hemorrhagic).

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026