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CompletedNCT05406297TAMIRUpdated Aug 16, 2022

Impact of TMAO Serum Levels on Hyperemic IMR in STEMI Patients

An observational study in STEMI - ST Elevation Myocardial Infarction and Microvascular Coronary Artery Disease, sponsored by Lithuanian University of Health Sciences. Completed at 1 site in Lithuania. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2022-08-16.

Sponsored by Lithuanian University of Health Sciences · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
40 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • STEMI - ST Elevation Myocardial Infarction
  • Microvascular Coronary Artery Disease
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 400 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Lithuanian University of Health Sciences is the lead sponsor of 102 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

This is a prospective, cohort study, conducted in the Hospital of the Lithuanian University of Health Sciences Kaunas Clinics.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (actual)
Patient registry
No

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.

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What researchers measure

Primary outcomes

  1. Index of microcirculatory resistance

    The index of microcirculatory resistance (IMR) will be detected using PressureWire™ X Guidewire

    Time frame: 3 months

Secondary outcomes

  1. Left ventricular ejection fraction

    left ventricular ejection fraction will be assessed via echocardiography imaging using Simpson's biplane method.

    Time frame: 3 months

  2. major adverse cardiovascular events (MACE)

    . 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).

    Time frame: up to 1 year

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Study locations

1 site
  • Ali Aldujeli
    Kaunas, LT-50161, Lithuania
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05406297
Lead sponsor
Lithuanian University of Health Sciences
Collaborators
Università degli Studi di Brescia, Kreiskrankenhaus Rotenburg
Responsible party
Ali Aldujeli (Cardiovascular disease consultant, Lithuanian University of Health Sciences) — Principal investigator
First posted
Jun 6, 2022
Start date
Jan 12, 2021
Primary completion
Jul 1, 2022
Completion
Aug 1, 2022
Last update
Aug 16, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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