Effect of Recombinant Human Brain Natriuretic Peptide on Ventricular Remodeling and Cardiac Function in Patients With Acute Anterior Myocardial Infraction Undergoing Percutaneous Coronary Intervention

NCT06463808 | Recruiting

• 1 other identifier: REBUILD-AAMI
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the efficacy and safety of Recombinant Human Brain Natriuretic Peptide (rhBNP) in improving ventricular remodeling and cardiac function after acute anterior myocardial infarction undergoing percutaneous coronary intervention. 100 patients with acute anterior myocardial infarction after primary Percutaneous Coronary Intervention (pPCI) are randomly assigned 1:1 to rhBNP group(n=50) and control group(n=50) with follow-up of 24 weeks. Both groups are treated with standard therapy of AAMI, with the rhBNP group intravenous dripping rhBNP after pPCI for 3 days and the control group treated with placebo at the same time. The primary endpoint is the change in N terminal pro-B-type natriuretic peptide（NT-proBNP ）and cardiac troponin T(cTnT) level.The secondary endpoint is the change in 24-week echocardiographic including left ventricle ejection fraction (LVEF) , left ventricular end-diastolic volume index (LVEDVI) and left ventricular end-systolic volume index (LVESVI), arrhythmia and cardiovascular events (death, cardiac arrest or cardiopulmonary resuscitation, hospitalization due to heart failure or angina pectoris).

Conditions

Ventricular Remodeling; Myocardial Infarction, Anterior Wall

Keywords

Myocardial Infarction, Anterior Wall; Recombinant Human Brain Natriuretic Peptide; Ventricular Remodeling; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (5)

• ultrasonic cardiogram：left ventricle ejection fraction (LVEF)

  LVEF refers to the percentage of stroke output to left ventricular end-diastolic

  from baseline to 6 months

• ultrasonic cardiogram：left ventricular end-diastolic volume index (LVEDVI)

  LVEDVI（ml/m2）=left ventricular end-diastolic volume（ml）/body surface area

  from baseline to 6 months

• ultrasonic cardiogram：left ventricular end-systolic volume index (LVESVI)

  LVESVI（ml/m2）=left ventricular end-systolic volume（ml）/body surface area

  from baseline to 6 months

• N terminal pro-B-type natriuretic peptide（NT-proBNP ）decline level

  NT-proBNP is a protein which is an "ingredient" for making the BNP hormone and a sign of heart failure can be obteined by blood

  from baseline to 6 months

• The level of Cardiac Troponin T(cTnT)

  The level of Cardiac Troponin T(cTnT) at 6 month

  from baseline to 6 months

Secondary Outcomes (1)

• Adverse cardiovascular events

  from baseline to 6 months

Study Arms (2)

patients who take Recombinant Human Brain Natriuretic Peptide

Drug: Recombinant Human Brain Natriuretic Peptide

patients who do not take Recombinant Human Brain Natriuretic Peptide

Interventions

Recombinant Human Brain Natriuretic Peptide DRUG

we divide our subjects into two groups;one is required to take recombinant human brain natriuretic peptide,the other is not required to take recombinant human brain natriuretic peptide

patients who take Recombinant Human Brain Natriuretic Peptide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People who are about 18 to 75 years old get the first acute anterior myocardial infarction ( AMI ) within 12 hours ( or more than 12 hours but the ischemic symptoms continue ) and undergo emergency PCI within the effective time window,after which the blood reflows ( TIMI = 3 ).

You may qualify if:

• The first acute anterior myocardial infarction ( AMI ) within 12 hours ( or more than 12 hours but the ischemic symptoms continue ).
• Age 18-75 years old, gender unlimited
• Patients with acute anterior myocardial infarction undergoing emergency PCI within the effective time window
• Successful reflow after interventional therapy ( TIMI = 3 ).
• To understand and sign the informed consent.

You may not qualify if:

• Patients with a history of coronary artery bypass grafting
• Patients with cardiogenic shock
• Patients with systolic blood pressure ( SBP ) ≤ 90 mmHg after treatment with vasopressors
• Patients with mechanical complications ( ventricular septal perforation, mitral chordae rupture )
• Patients with suspected aortic dissection
• Patients with severe liver and kidney dysfunction
• Allergic or intolerant to rhBNP.
• Patients with chronic renal insufficiency requiring long-term dialysis
• Patients using diuretics during the screening period
• Pregnant / lactating women
• Heart diseases that are not suitable for vasodilators, such as severe valve stenosis, restrictive cardiomyopathy, restrictive pericarditis, etc

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Ventricular Remodeling; Anterior Wall Myocardial Infarction

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis

Central Study Contacts

LianSheng Wang

CONTACT

1339078711; drlswang@njmu.edu.cn

Yang Yang

CONTACT

15895876832; 273389782@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: June 18, 2024
• Study Start: May 3, 2023
• Primary Completion: December 31, 2024
• Study Completion: February 28, 2025
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

CN (1)