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

NCT06836531 | Enrolling By Invitation

• 2 other identifiers: 2024135A2023S193
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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. 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. 2.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)

Outcome Measures

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.

  From enrollment to the end of treatment at 1 hour

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Ningbo University: lead

Study Sites (1)

First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: February 20, 2025
• Study Start: March 30, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)