POCT Detection for Blood Concentration of Tirofiban in Ac... | NCT06836531

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

NCT06836531

Sponsor

First Affiliated Hospital of Ningbo University

Status

Enrolling by invitation

Last Update Posted

Mar 25, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Acute Myocardial Infarction (AMI)

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2023S193	Other Grant/Funding Number	Ningbo Public Welfare Research Program

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2025Estimated

Primary Completion Date

Jul 31, 2025Estimated

Completion Date

Jul 31, 2025Estimated

First Submitted Date

Nov 28, 2024

First Submission Date that Met QC Criteria

Feb 19, 2025

First Posted Date

Feb 20, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2025

Last Update Posted Date

Mar 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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:

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
First Affiliated Hospital of Ningbo University		Ningbo	Zhejiang	315010	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided