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

F

First Affiliated Hospital of Ningbo University

Status

Invitation-only

Conditions

Acute Myocardial Infarction (AMI)

Study type

Observational

Funder types

NETWORK

Identifiers

NCT06836531
2024135A
2023S193 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

100 participants in 3 patient groups

Healthy
Description:
those without coronary atherosclerotic heart disease
AMI
Description:
those with acute myocardial infarction but without percutaneous coronary intervention
AMI-PCI
Description:
those with acute myocardial infarction and percutaneous coronary intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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