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The purpose of this study is to determine the efficacy of intravenous human beta natriuretic peptide (BNP, Nesiritide) as compared to placebo to prevent adverse post acute myocardial infarction left ventricular remodeling.
Post acute myocardial infarction (AMI) left ventricular (LV) remodeling begins within hours of the acute event with permanent consequences. Previous studies have demonstrated that LV remodeling is one of the major determinants of long-term survival post AMI. Recent studies have reported that the cardiac natriuretic peptides, atrial natriuretic peptide (ANP) and BNP have direct anti-fibrotic and anti-proliferative effects on the myocardium. More importantly, it has been reported that in the acute phase of AMI, the secretion of the cardiac natriuretic peptides may be insufficient relative to the chronic phase. Therefore, augmentation of the cardiac natriuretic peptide system, such as by exogenous administration of exogenous peptide may prevent post AMI LV remodeling because of the cardioprotective effects. The objective of this study is to to determine the efficacy of IV human BNP (Nesiritide) as compared to placebo to prevent adverse post AMI LV remodeling. This is a randomized double blinded placebo controlled study to determine efficacy of 72 hours of IV BNP at 0.006µg/Kg/min as compared to placebo in patients with anterior ST-elevation myocardial infarction and successful revascularization. The study population will include 60 patients admitted to the Cardiac Care Unit with a first anterior AMI and successful reperfusion therapy (TIMI grade 3 flow) within 24 hours of onset of chest pain documented by coronary angiography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Infusion of 72 hours of saline solution (packaged to match active comparator). |
|
| Nesiritide | Active Comparator | Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nesiritide | Drug | Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricular End-Systolic Volume Index | Change in Left Ventricular end-systolic volume index as determined by Multiple Gated Acquisition (MUGA) scan from baseline to 30 days. The MUGA scan is a noninvasive tool for assessing the function of the heart. The MUGA scan produces a moving image of the beating heart, and from this image several important features can be determined about the health of the cardiac ventricles (the heart's major pumping chambers). End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. ESV is the lowest volume of blood in the ventricle at any point in the cardiac cycle and can be used clinically as a measurement of the adequacy of cardiac emptying, related to systolic function. | baseline, 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricular End-Systolic Diastolic Volume Index | Change in Left Ventricular end-systolic diastolic volume index determined by Multiple Gated Acquisition (MUGA) scan from baseline to 30 days. The MUGA scan is a noninvasive tool for assessing the function of the heart. The MUGA scan produces a moving image of the beating heart, and from this image several important features can be determined about the health of the cardiac ventricles (the heart's major pumping chambers). End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. ESV is the lowest volume of blood in the ventricle at any point in the cardiac cycle and can be used clinically as a measurement of the adequacy of cardiac emptying, related to systolic function. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Horng H. Chen, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Jacksonvilee | Florida | 32224 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32747497 | Derived | Hubers SA, Schirger JA, Sangaralingham SJ, Chen Y, Burnett JC Jr, Hodge D, Chen HH. B-type natriuretic peptide and cardiac remodelling after myocardial infarction: a randomised trial. Heart. 2021 Mar;107(5):396-402. doi: 10.1136/heartjnl-2020-317182. Epub 2020 Aug 3. |
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One subject withdrew consent before randomization.
Subjects were recruited at the Mayo Clinic Cardiac Care Units in Rochester, Minnesota and Jacksonville, Florida.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Infusion of 72 hours of saline solution (packaged to match active comparator). |
| FG001 | Nesiritide | Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline values are reported for subjects completing the study (28 in placebo group and 25 in nesiritide group).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Infusion of 72 hours of saline solution (packaged to match active comparator). |
| BG001 | Nesiritide | Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Left Ventricular End-Systolic Volume Index | Change in Left Ventricular end-systolic volume index as determined by Multiple Gated Acquisition (MUGA) scan from baseline to 30 days. The MUGA scan is a noninvasive tool for assessing the function of the heart. The MUGA scan produces a moving image of the beating heart, and from this image several important features can be determined about the health of the cardiac ventricles (the heart's major pumping chambers). End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. ESV is the lowest volume of blood in the ventricle at any point in the cardiac cycle and can be used clinically as a measurement of the adequacy of cardiac emptying, related to systolic function. | Posted | Mean | Standard Deviation | mL of blood/meter^2 body surface area | baseline, 30 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Infusion of 72 hours of saline solution (packaged to match active comparator). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left ventricle aneurysm or thrombus | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Horng H. Chen | Mayo Clinic | 507-284-1644 | chen.horng@mayo.edu |
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| ID | Term |
|---|---|
| D020097 | Natriuretic Peptide, Brain |
| ID | Term |
|---|---|
| D045265 | Natriuretic Peptides |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Placebo | Drug | Infusion of 72 hours of saline solution (packaged to match active comparator) |
|
| baseline, 30 days |
| Myocardial Infarct Size at 30 Days | Myocardial infarction or acute myocardial infarction (AMI) is the medical term for an event commonly known as a heart attack. Myocardial (heart muscle) infarction is tissue death (also known as necrosis) caused by a local lack of oxygen, due to an obstruction of the tissue's blood supply. The resulting heart tissue lesion is referred to as an infarct. A larger size or area of infarct indicates a greater amount of heart tissue death. Myocardial infarct size was measured using a cardiac Magnetic Resonance Imaging (MRI) scan at 30 days and is the mass of the infarcted tissue divided by the mass of the left ventricle times 100%. | 30 days |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Nesiritide | Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min. Nesiritide: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min. |
|
|
|
| Secondary | Change in Left Ventricular End-Systolic Diastolic Volume Index | Change in Left Ventricular end-systolic diastolic volume index determined by Multiple Gated Acquisition (MUGA) scan from baseline to 30 days. The MUGA scan is a noninvasive tool for assessing the function of the heart. The MUGA scan produces a moving image of the beating heart, and from this image several important features can be determined about the health of the cardiac ventricles (the heart's major pumping chambers). End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. ESV is the lowest volume of blood in the ventricle at any point in the cardiac cycle and can be used clinically as a measurement of the adequacy of cardiac emptying, related to systolic function. | Posted | Mean | Standard Deviation | mL blood/meter^2 body surface area | baseline, 30 days |
|
|
|
|
| Secondary | Myocardial Infarct Size at 30 Days | Myocardial infarction or acute myocardial infarction (AMI) is the medical term for an event commonly known as a heart attack. Myocardial (heart muscle) infarction is tissue death (also known as necrosis) caused by a local lack of oxygen, due to an obstruction of the tissue's blood supply. The resulting heart tissue lesion is referred to as an infarct. A larger size or area of infarct indicates a greater amount of heart tissue death. Myocardial infarct size was measured using a cardiac Magnetic Resonance Imaging (MRI) scan at 30 days and is the mass of the infarcted tissue divided by the mass of the left ventricle times 100%. | Posted | Mean | Standard Deviation | percentage of total cardiac tissue mass | 30 days |
|
|
|
|
| 5 |
| 28 |
| 13 |
| 28 |
| EG001 | Nesiritide | Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min. | 1 | 25 | 13 | 25 |
| Hospital readmission for chest pain | Cardiac disorders | Systematic Assessment |
|
| Hospital readmission for other reasons (not chest pain) | General disorders | Systematic Assessment |
|
| Post coronary angiogram related complications | Cardiac disorders | Systematic Assessment |
|
| Subsequent coronary angiogram with no intervention | Cardiac disorders | Systematic Assessment |
|
| Subsequent coronary angiogram with intervention other than LAD | Cardiac disorders | Systematic Assessment |
|
| Persistent ECG ST changes | Cardiac disorders | Systematic Assessment |
|
| Recurrent chest pain | Cardiac disorders | Systematic Assessment |
|
| Vasovagal spell | Cardiac disorders | Systematic Assessment |
|
| MRI dye allergy | General disorders | Systematic Assessment |
|
| Asthma flare | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fever | Infections and infestations | Systematic Assessment |
|
| First episode of hypotension (asymptomatic) | Cardiac disorders | Systematic Assessment |
|
| First episode of hypotension (symptomatic) | Cardiac disorders | Systematic Assessment |
|
| Second episode of hypotension (asymptomatic) | Cardiac disorders | Systematic Assessment |
|
| Second episode of hypotension (symptomatic) | Cardiac disorders | Systematic Assessment |
|
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| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |