Acute Myocardial Infarction (AMI)NCT06836531
POCT Detection for Blood Concentration of Tirofiban in Acute Myocardial Infarction Based on Azo-POP Probe.
An observational study of Acute Myocardial Infarction (AMI), run by First Affiliated Hospital of Ningbo University at 1 site in China.
Trial summary
The goal of this observational study is to monitor blood drug concentration during the use of tirofiban, predict the occurrence of intraoperative and postoperative complications related to interventional therapy, and evaluate the efficacy of multiple antiplatelet drugs.The main question it aims to answer is: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myocardial Infarction (AMI)
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2025to 31 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients are diagnosed with acute myocardial infarction and treated with direct PCI in the cardiology department of our hospital during the project execution period.
Who may be able to join
- The patient meets the diagnostic criteria for STEMI (refer to the "Diagnosis and Treatment Guidelines for Acute ST Segment Elevation Myocardial Infarction (2019)")
- The onset time is less than 12 hours
- Agree to perform direct PCI
- Heart function (Killip class) ≤ Level III
- There are no direct PCI contraindications.
Who cannot join
- Patients allergic to tirofiban or/and aspirin
- Patients with a history of intracranial hemorrhage
- Patients with stroke/transient ischemic attack within six months
- Patients who have taken oral anticoagulants within 30 days before admission and cannot stop taking them
- Patients receiving clopidogrel or ticagrelor from other manufacturers or formulations due to directive events
- Patients who have received or plan to undergo fibrinolysis therapy within 24 hours
Show all 10Show fewer
- Patients with a history of major surgery within 30 days, or those who plan to undergo major surgery during the study process
- Patients with a history of gastrointestinal bleeding within 6 months, or those with severe bleeding disorders or tendencies towards bleeding
- Patients with severe combined liver and kidney dysfunction
- Refuse to participate in this experiment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010
About this study
Official title: POCT Detection for Blood Concentration of Tirofiban in Acute Myocardial Infarction Based on Azo-POP Probe, and Use Metabolomics Analysis Combined with Machine Learning Algorithms for Screening Biomarkers of Myocardial Infarction.
The goal of this observational study is to monitor blood drug concentration during the use of tirofiban, predict the occurrence of intraoperative and postoperative complications related to interventional therapy, and evaluate the efficacy of multiple antiplatelet drugs.The main question it aims to answer is:
- If the POCT detection technology for blood concentration of tirofiban based on portable mass spectrometer can be used for on-site sampling, clinical testing, and immediate analysis next to patients undergoing coronary intervention therapy.
- LC-MS/MS untargeted metabolomics analysis techniques combined with machine learning algorithms will be used to screen biomarkers for myocardial infarction.
- Conditions
- Acute Myocardial Infarction (AMI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | those without coronary atherosclerotic heart disease | |
| AMI | those with acute myocardial infarction but without percutaneous coronary intervention | |
| AMI-PCI | those with acute myocardial infarction and percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a POCT detection technology for blood concentration of tirofiban based on portable mass spectrometer, which can perform on-site sampling, clinical testing, and immediate analysis during PCI.
Measured: From enrollment to the end of treatment at 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start30 Mar 2025 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction (AMI)Studies 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Ningbo University
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836531
- Sponsor's protocol ID
- 2024135A
- Other IDs
- 2023S193
- Status last verified
- Mar 2025
- First submitted
- 28 Nov 2024
- Last updated
- 25 Mar 2025
- 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 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POCT Detection for Blood Concentration of Tirofiban in Acute Myocardial Infarction Based on Azo-POP Probe, and Use Metabolomics Analysis Combined with Machine Learning Algorithms for Screening Biomarkers of Myocardial Infarction.
- ClinicalTrials.gov ID
- NCT06836531
- Acronym / sponsor ID
- 2024135A
- Conditions
- Acute Myocardial Infarction (AMI)
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Ningbo UniversityResearch network
- Study start
- 30 Mar 2025 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 20 Feb 2025 (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.
The goal of this observational study is to monitor blood drug concentration during the use of tirofiban, predict the occurrence of intraoperative and postoperative complications related to interventional therapy, and evaluate the efficacy of multiple antiplatelet drugs.The main question it aims to answer is:
- If the POCT detection technology for blood concentration of tirofiban based on portable mass spectrometer can be used for on-site sampling, clinical testing, and immediate analysis next to patients undergoing coronary intervention therapy.
- LC-MS/MS untargeted metabolomics analysis techniques combined with machine learning algorithms will be used to screen biomarkers for myocardial infarction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | –those without coronary atherosclerotic heart disease |
| AMI | – | –those with acute myocardial infarction but without percutaneous coronary intervention |
| AMI-PCI | – | –those with acute myocardial infarction and percutaneous coronary intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are diagnosed with acute myocardial infarction and treated with direct PCI in the cardiology department of our hospital during the project execution period.
Key inclusion criteria (5 listed)
- The patient meets the diagnostic criteria for STEMI (refer to the "Diagnosis and Treatment Guidelines for Acute ST Segment Elevation Myocardial Infarction (2019)")
- The onset time is less than 12 hours
- Agree to perform direct PCI
- Heart function (Killip class) ≤ Level III
- There are no direct PCI contraindications.
Key exclusion criteria (10 listed)
- Patients allergic to tirofiban or/and aspirin
- Patients with a history of intracranial hemorrhage
- Patients with stroke/transient ischemic attack within six months
- Patients who have taken oral anticoagulants within 30 days before admission and cannot stop taking them
- Patients receiving clopidogrel or ticagrelor from other manufacturers or formulations due to directive events
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
Establish a POCT detection technology for blood concentration of tirofiban based on portable mass spectrometer, which can perform on-site sampling, clinical testing, and immediate analysis during PCI.
Time frame: From enrollment to the end of treatment at 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- 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.
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 Acute Myocardial Infarction (AMI), run by First Affiliated Hospital of Ningbo University at 1 site in China.
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 5 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 25 Mar 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Establish a POCT detection technology for blood concentration of tirofiban based on portable mass spectrometer, which can perform on-site sampling, clinical testing, and immediate analysis during PCI. (time frame: From enrollment to the end of treatment at 1 hour). 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 25 Mar 2025.