Myocardial InfarctionNCT03418285
Trimethylamine N-oxide in Myocardial Infarction
An observational study of Myocardial Infarction, run by Yokohama City University Medical Center.
Trial summary
Trimethylamine-N-oxide (TMAO) is produced from the metabolism of gut microbiota and is reportedly pro-atherogenic and associated with cardiovascular events. The purpose of this study is to investigate the sequential change in TMAO levels by current optimal secondary prevention therapies in patients with ST-elevation… Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Myocardial Infarction
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2007to 1 Jan 2018
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: STEMI
Who may be able to join
- Patients who admitted to the Yokohama City University Medical Center with the diagnosis of their first STEMI and who underwent primary percutaneous coronary intervention within 12 hours after onset and received follow-up coronary angiogram 10 months after the index intervention.
Who cannot join
- none
About this study
Official title: Microbiota-derived Trimethylamine N-oxide as Residual Risk After ST-elevation Myocardial Infarction
Trimethylamine-N-oxide (TMAO) is produced from the metabolism of gut microbiota and is reportedly pro-atherogenic and associated with cardiovascular events. The purpose of this study is to investigate the sequential change in TMAO levels by current optimal secondary prevention therapies in patients with ST-elevation acute myocardial infarction (STEMI) and the clinical impact of TMAO levels on the progression of atherosclerosis and subsequent cardiovascular events.
Read the detailed description
This study includes patients with their first STEMI. The investigators measure plasma TMAO levels using the frozen plasma at the onset of STEMI and 10 months later (the chronic phase). To assess plaque progression, residual SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score and chronic-phase SYNTAX score are measured. After the chronic-phase assessment of TMAO and SYNTAX score, patients are followed for cardiovascular events including death, myocardial infarction, ischemic stroke, and unstable angina pectoris with coronary revascularization.
- Conditions
- Myocardial Infarction
- Medical subject headings
- Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
death, myocardial infarction, ischemic stroke, and unstable angina pectoris with coronary revascularization
Measured: 6 years
Secondary outcomes (1)
Coronary plaque progression
the highest tertile of change in SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score.
Higher SYNTAX score indicates more complicated coronary plaque. minimum 0, maximum 80.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start1 Jan 2007
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yokohama City University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasushi Matsuzawa, Yokohama City University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418285
- Sponsor's protocol ID
- TMAO_STEMI
- Status last verified
- Jan 2018
- First submitted
- 25 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiota-derived Trimethylamine N-oxide as Residual Risk After ST-elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03418285
- Acronym / sponsor ID
- TMAO_STEMI
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Yokohama City University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 1 Feb 2018 (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 produced from the metabolism of gut microbiota and is reportedly pro-atherogenic and associated with cardiovascular events. The purpose of this study is to investigate the sequential change in TMAO levels by current optimal secondary prevention therapies in patients with ST-elevation acute myocardial infarction (STEMI) and the clinical impact of TMAO levels on the progression of atherosclerosis and subsequent cardiovascular events.
Detailed description
This study includes patients with their first STEMI. The investigators measure plasma TMAO levels using the frozen plasma at the onset of STEMI and 10 months later (the chronic phase). To assess plaque progression, residual SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score and chronic-phase SYNTAX score are measured. After the chronic-phase assessment of TMAO and SYNTAX score, patients are followed for cardiovascular events including death, myocardial infarction, ischemic stroke, and unstable angina pectoris with coronary revascularization.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- STEMI
Key inclusion criteria (1 listed)
- Patients who admitted to the Yokohama City University Medical Center with the diagnosis of their first STEMI and who underwent primary percutaneous coronary intervention within 12 hours after onset and received follow-up coronary angiogram 10 months after the index intervention.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MACE
Time frame: 6 years
death, myocardial infarction, ischemic stroke, and unstable angina pectoris with coronary revascularization
1 secondary outcome
Coronary plaque progression
Time frame: 10 months
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 5 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Yokohama City University Medical Center.
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 1 inclusion and 1 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 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
MACE (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2018.