Impact of TMAO Serum Levels on Hyperemic IMR in STEMI Patients

Completed

• Conditions: STEMI - ST Elevation Myocardial Infarction; Microvascular Coronary Artery Disease

• Registration Number: NCT05406297
• Lead Sponsor: Lithuanian University of Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-12
• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-06
• Primary Completion: 2022-07-01
• Status Verified: 2022-08
• Study Completion: 2022-08-01
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Index of microcirculatory resistance	3 months	The index of microcirculatory resistance (IMR) will be detected using PressureWire™ X Guidewire

Secondary Outcome Measures

Name	Time	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).
Left ventricular ejection fraction	3 months	left ventricular ejection fraction will be assessed via echocardiography imaging using Simpson's biplane method.

Trial Locations

Locations (1)

Ali Aldujeli; 🇱🇹 Kaunas, Lithuania