Clinical trial NCT06836531: POCT Detection for Blood Concentration of Tirofiban in Acute Myocardial Infarction Based on Azo-POP Probe.
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.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Acute Myocardial Infarction (AMI)
Lead sponsor: First Affiliated Hospital of Ningbo University
Sponsor class: NETWORK
First posted: 2025-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.
2. LC-MS/MS untargeted metabolomics analysis techniques combined with machine learning algorithms will be used to screen biomarkers for myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
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.
timeFrame: From enrollment to the end of treatment at 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Ningbo
country: China
facility: First Affiliated Hospital of Ningbo University
state: Zhejiang
Study officials:
References: