Impact of TMAO Serum Levels on Hyperemic IMR in STEMI Patients (TAMIR)

August 15, 2022 updated by: Ali Aldujeli, Lithuanian University of Health Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Procedure: pressure-temperature sensor guidewire-based measurement

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Lithuania
- - Kaunas, Lithuania, LT-50161
    - Ali Aldujeli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Index of microcirculatory resistance Time Frame: 3 months	The index of microcirculatory resistance (IMR) will be detected using PressureWire™ X Guidewire	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular ejection fraction Time Frame: 3 months	left ventricular ejection fraction will be assessed via echocardiography imaging using Simpson's biplane method.	3 months
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).	up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lithuanian University of Health Sciences

Collaborators

Università degli Studi di Brescia

Kreiskrankenhaus Rotenburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2021

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

June 1, 2022

First Submitted That Met QC Criteria