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Enrolling by Invitation

NCT Number: NCT06836531

POCT Detection for Blood Concentration of Tirofiban in Acute Myocardial Infarction Based on Azo-POP Probe.

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.

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Key information

Conditions

Acute Myocardial Infarction (AMI)

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Ningbo University

Network

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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