NCT05723315

Brief Summary

The target population of this interventional study was STEMI patients. Primary discussion: Early rhBNP reduces microcirculation obstruction in STEMI patients undergoing primary PCI

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

1.8 years

First QC Date

February 1, 2023

Last Update Submit

February 1, 2023

Conditions

STEMI

Outcome Measures

Primary Outcomes (1)

  • MVO/LV(%)

    Microvascular obstruction assessed by magnetic resonance imaging

    3-14 days after PPCI

Secondary Outcomes (7)

  • LGE/LV(%)

    3-14 days and 90±7 days after PPCI

  • IMH

    3-14 days after PPCI

  • MVO/LV(%)

    30±7 days after PPCI

  • LVEDV(ml)

    3-14 days and 90±7 days after PPCI

  • LVESV(ml)

    3-14 days and 90±7 days after PPCI

  • +2 more secondary outcomes

Study Arms (2)

Experimental Group 1

EXPERIMENTAL

The experimental group was given neoptin within 3h after PCI for 72 hours (first at 1.5μg /kg intravenous load, then at 0.015μg /kg/min).

Drug: recombinant human B-type natriuretic peptide

Control Gruop

NO INTERVENTION

The experimental group was given an intravenous infusion of the same amount of normal saline

Interventions

recombinant human B-type natriuretic peptideDRUG

The recombinant human B-type natriuretic peptide produces physiological effects by imitating endogenous B-type natriuretic peptide

Also known as: rhBNP
Experimental Group 1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • STEMI
  • PPCI within 24 hours of symptom onset
  • Target vessel QFR-MR\>250mm Hg\*s/m

You may not qualify if:

  • claustrophobia
  • Postoperative TIMI grade 0-1
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Muwei Li, MD

    Fuwai central China cardiovascular hospotial

    STUDY CHAIR

Central Study Contacts

Quan Guo

CONTACT

+8615670510031xinyiguoquan@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 10, 2023

Study Start

February 20, 2023

Primary Completion

December 20, 2024

Study Completion

December 20, 2025

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share