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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05723315
Other study ID # HenanICE202301
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 20, 2023
Est. completion date December 20, 2025

Study information

Verified date February 2023
Source Henan Institute of Cardiovascular Epidemiology
Contact Quan Guo
Phone +8615670510031
Email xinyiguoquan@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 160
Est. completion date December 20, 2025
Est. primary completion date December 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • ST Elevation Myocardial Infarction
  • STEMI

Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Henan Institute of Cardiovascular Epidemiology

Outcome

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