Impact of TMAO Serum Levels on Hyperemic IMR in STEMI Patients

NCT ID: NCT05406297

Last Updated: 2022-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-12

Study Completion Date

2022-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

STEMI - ST Elevation Myocardial Infarction Microvascular Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Università degli Studi di Brescia

OTHER

Sponsor Role collaborator

Kreiskrankenhaus Rotenburg

UNKNOWN

Sponsor Role collaborator

Lithuanian University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ali Aldujeli

Cardiovascular disease consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ali Aldujeli

Kaunas, , Lithuania

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Lithuania

References

Explore related publications, articles, or registry entries linked to this study.

Aldujeli A, Tsai TY, Haq A, Tatarunas V, Garg S, Hughes D, Ciapiene I, Unikas R, Sharif F, Lesauskaite V, Onuma Y, Serruys PW. The association between trimethylamine N-oxide levels and coronary microvascular dysfunction and prognosis in patients with ST-elevation myocardial infarction. Atherosclerosis. 2024 Nov;398:118597. doi: 10.1016/j.atherosclerosis.2024.118597. Epub 2024 Sep 12.

Reference Type DERIVED
PMID: 39316928 (View on PubMed)

Tsai TY, Aldujeli A, Haq A, Knokneris A, Briedis K, Hughes D, Unikas R, Renkens M, Revaiah PC, Tobe A, Miyashita K, Sharif F, Garg S, Onuma Y, Serruys PW. The Impact of Microvascular Resistance Reserve on the Outcome of Patients With STEMI. JACC Cardiovasc Interv. 2024 May 27;17(10):1214-1227. doi: 10.1016/j.jcin.2024.03.024. Epub 2024 May 14.

Reference Type DERIVED
PMID: 38752970 (View on PubMed)

Aldujeli A, Tsai TY, Haq A, Tatarunas V, Knokneris A, Briedis K, Unikas R, Onuma Y, Brilakis ES, Serruys PW. Impact of Coronary Microvascular Dysfunction on Functional Left Ventricular Remodeling and Diastolic Dysfunction. J Am Heart Assoc. 2024 May 7;13(9):e033596. doi: 10.1161/JAHA.123.033596. Epub 2024 Apr 30.

Reference Type DERIVED
PMID: 38686863 (View on PubMed)

Aldujeli A, Haq A, Tsai TY, Grabauskyte I, Tatarunas V, Briedis K, Rana S, Unikas R, Hamadeh A, Serruys PW, Brilakis ES. The impact of primary percutaneous coronary intervention strategies during ST-elevation myocardial infarction on the prevalence of coronary microvascular dysfunction. Sci Rep. 2023 Nov 16;13(1):20094. doi: 10.1038/s41598-023-47343-x.

Reference Type DERIVED
PMID: 37973856 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LUHSKC-176

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.