Impact of TMAO Serum Levels on Hyperemic IMR in STEMI Patients

STEMI - ST Elevation Myocardial Infarction Clinical Trial

— TAMIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05406297
• Other study ID #: LUHSKC-176
• Status: Completed
• Start date: January 12, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: August 2022
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: August 1, 2022
• Est. primary completion date: July 1, 2022
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• pressure-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.

Locations

Country	Name	City	State
Lithuania	Ali Aldujeli	Kaunas

Sponsors (3)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences	Kreiskrankenhaus Rotenburg, Università degli Studi di Brescia

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Index of microcirculatory resistance	The index of microcirculatory resistance (IMR) will be detected using PressureWire™ X Guidewire	3 months
Secondary	Left ventricular ejection fraction	left ventricular ejection fraction will be assessed via echocardiography imaging using Simpson's biplane method.	3 months
Secondary	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).	up to 1 year