Effect of rhBNP on CMD in Patients With STEMI After PPCI

Effect of rhBNP on Coronary Microcirculation in Patients With Acute ST-segment Elevation Myocardial Infarction After Primary PCI

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

Study Overview

• Status: Not yet recruiting
• Conditions: STEMI
• Intervention / Treatment: Drug: recombinant human B-type natriuretic peptide

Detailed Description

Direct percutaneous coronary intervention is the preferred reperfusion strategy for acute ST-segment elevation myocardial infarction. During the opening of infarct-related vessels, 5%-50% of patients showed slow flow or no reflow and other coronary microcirculation dysfunction, which aggravated myocardial injury and increased the incidence and mortality of heart failure. Studies have shown that recombinant human brain natriuretic peptide (rhBNP) can reduce reperfusion injury and reduce myocardial infarction area CMD. Prolonged ischemia leads to rapid depletion of intracellular ATP and tissue metabolic acidosis. Blood flow irrigation during reperfusion leads to decreased levels of ATP precursors, calcium overload in mitochondria, release of a large number of inflammatory factors and oxygen free radicals, which can lead to injury or death of myocardial and endothelial cells. rhBNP can enhance the activity of antioxidant enzymes, reduce the irreversible oxidative damage caused by free radicals to myocardium, reduce the myocardial infarction area during ischemia reperfusion, and may reduce the reperfusion injury and protect the viable myocardium.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Quan Guo; Phone Number: +8615670510031; Email: xinyiguoquan@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• claustrophobia
• Postoperative TIMI grade 0-1
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental Group 1; 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; The recombinant human B-type natriuretic peptide produces physiological effects by imitating endogenous B-type natriuretic peptide; Other Names: rhBNP
NO_INTERVENTION: Control Gruop; The experimental group was given an intravenous infusion of the same amount of normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MVO/LV(%)	Microvascular obstruction assessed by magnetic resonance imaging	3-14 days after PPCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LGE/LV(%)	Cardiac magnetic resonance imaging	3-14 days and 90±7 days after PPCI
IMH	Intramuscular hemorrhageCardiac assessed by magnetic resonance imaging	3-14 days after PPCI
MVO/LV(%)	Microvascular obstruction assessed by magnetic resonance imaging	30±7 days after PPCI
LVEDV(ml)	Assessed by magnetic resonance imaging	3-14 days and 90±7 days after PPCI
LVESV(ml)	Assessed by magnetic resonance imaging	3-14 days and 90±7 days after PPCI
Troponin (highest value)	Troponin (highest value)	3-14 days after PPCI
MACCEs	Major Adverse Cardiac and Cerebrovascular event：Death, nonfatal myocardial infarction, heart failure, revascularization, stroke	7days，30days，3months，6 months

Collaborators and Investigators

• Sponsor: Henan Institute of Cardiovascular Epidemiology

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 20, 2023
• Primary Completion (ANTICIPATED): December 20, 2024
• Study Completion (ANTICIPATED): December 20, 2025

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (ACTUAL): February 10, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Physiological Effects of Drugs; Natriuretic Agents; Natriuretic Peptide, Brain
• Other Study ID Numbers: HenanICE202301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No