STEMI - ST Elevation Myocardial InfarctionTAMIRNCT05406297
Impact of TMAO Serum Levels on Hyperemic IMR in STEMI Patients
An observational study of STEMI - ST Elevation Myocardial Infarction and Microvascular Coronary Artery Disease, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction, Microvascular Coronary Artery Disease
- What is being tested?
- pressure-temperature sensor guidewire-based measurement
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteLithuania
- Study dates
- 12 Jan 2021to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Adult, Older adult
Study population: This is a prospective, cohort study, conducted in the Hospital of the Lithuanian University of Health Sciences Kaunas Clinics.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Being tested
- pressure-temperature sensor guidewire-based measurement
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pressure-temperature sensor guidewire-based measurementProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Index of microcirculatory resistance
The index of microcirculatory resistance (IMR) will be detected using PressureWire™ X Guidewire
Measured: 3 months
Secondary outcomes (2)
Left ventricular ejection fraction
left ventricular ejection fraction will be assessed via echocardiography imaging using Simpson's biplane method.
Measured: 3 months
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).
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start12 Jan 2021
- Primary completion1 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Brescia, Kreiskrankenhaus Rotenburg
- Responsible party
- Principal investigator, Ali Aldujeli, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406297
- Sponsor's protocol ID
- LUHSKC-176
- Acronym
- TAMIR
- Status last verified
- Aug 2022
- First submitted
- 1 Jun 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39316928Tsai 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.
PubMed 38752970Aldujeli 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.
PubMed 38686863Aldujeli 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.
PubMed 37973856
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05406297
- Acronym / sponsor ID
- TAMIR / LUHSKC-176
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- Università degli Studi di Brescia, Kreiskrankenhaus Rotenburg
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This is a prospective, cohort study, conducted in the Hospital of the Lithuanian University of Health Sciences Kaunas Clinics.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (14 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pressure-temperature sensor guidewire-based measurementIn 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. | Procedure or surgery | – |
Primary outcome
Index of microcirculatory resistance
Time frame: 3 months
The index of microcirculatory resistance (IMR) will be detected using PressureWire™ X Guidewire
2 secondary outcomes
Left ventricular ejection fraction
Time frame: 3 months
major adverse cardiovascular events (MACE)
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Derived from this study: PubMed 39316928Aldujeli 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.
- Derived from this study: PubMed 38752970Tsai 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.
- Derived from this study: PubMed 38686863Aldujeli 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.
- Derived from this study: PubMed 37973856Aldujeli 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI - ST Elevation Myocardial Infarction and Microvascular Coronary Artery Disease, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Index of microcirculatory resistance (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05406297, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.