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OpenTrials
Completed

NCT Number: NCT05406297

Impact of TMAO Serum Levels on Hyperemic IMR in STEMI Patients

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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Key information

Conditions

STEMI - ST Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Microvascular Coronary Artery Disease Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ali Aldujeli

Kaunas, LT-50161, Lithuania

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

pressure-temperature sensor guidewire-based measurement

Procedure

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.

Primary outcomes

  1. Index of microcirculatory resistance

    Time frame: 3 months

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

Secondary outcomes

  1. Left ventricular ejection fraction

    Time frame: 3 months

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

  2. major adverse cardiovascular events (MACE)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Collaborators

  • Kreiskrankenhaus Rotenburg
  • Università degli Studi di Brescia

Registry information

Official study title

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

Acronym: TAMIR

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 6, 2022
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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