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Sodium Tanshinone IIA Sulfonate in Left Ventricular Remodeling Secondary to Acute Myocardial Infarction

Primary Purpose

Left Ventricular Remodeling, Acute Myocardial Infarction

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
sodium tanshinone IIA sulfonate
control
Sponsored by
Guangdong Provincial Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Left Ventricular Remodeling focused on measuring left ventricular remodeling, cardiac magnetic resonance imaging, acute myocardial infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1.Aged 18 years or over and under 80 years;
  • 2. First-time myocardial infarction on admission;
  • 3. Presence of STEMI who has successfully coronary recanalization by PCI within 12 h after the symptom onset;
  • 4. Willingness to provide informed consent prior to enrollment;
  • 5. Patient is able to comply with all follow-up evaluation

Exclusion Criteria:

  • 1. Contraindications to performance of CMRI [pacemakers, implantable cardioverter/defibrillator devices, cardiac resynchronization therapy (CRT), claustrophobia, metal implants (joint prosthesis, et al), history of penetrative eye lesion];
  • 2. Previous myocardial infarction, arrhythmia (including atrial fibrillation or bundle brunch block), significant valvular disease, and hypertrophic cardiomyopathy;
  • 3. Severe heart failure (NYHA cardiac function class IV or left ventricular ejection fraction≤30%) or cardiogenic shock;
  • 4. Serious impairment of renal function (glomerular filtration rate ≤50 mL/min per 1.73 m2);
  • 5. Hypohepatia (elevated of alanine aminotransferase and aspartate aminotransferase serum levels);
  • 6. Severe coagulopathy prior to randomization;
  • 7. Malignant tumors or other life-threatening diseases with limited life expectancy <1 year;
  • 8. Significant neuropsychopathic condition precluding written informed consent;
  • 9. Pregnant and lactating women;
  • 10. Known radiographic contrast or sodium tanshinone IIA sulfonate allergy;
  • 11. Be on therapy with immunosuppressants;
  • 12. Currently participated in any other investigational therapeutic or device trial;
  • 13. Clinical follow-up over the next half years not possible

Sites / Locations

  • Guangdong Provincial Hospital of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

sodium tanshinone IIA sulfonate

control

Arm Description

sodium tanshinone IIA sulfonate (80 mg q.d. for 7 days)

same volume/day of normal saline.

Outcomes

Primary Outcome Measures

left ventricular end-diastolic volume index
The primary endpoint is to determine whether sodium tanshinone IIA sulfonate could prevent LV remodeling among patients with completely reperfused AMI after PCI, detected by 6 month change in left ventricular end-diastolic volume index (mL/m^2) measured using cardiac magnetic resonance imaging .

Secondary Outcome Measures

cardiac magnetic resonance imaging measures of LV remolding
cardiac magnetic resonance imaging measures of variations in left ventricular end-systolic/ diastolic volume (mL) during the same interval.
cardiac magnetic resonance imaging measures of microvascular obstruction
cardiac magnetic resonance imaging measures of the frequency of delayed or absent wash-in of contrast agent into the infarct zone.
variation (change from baseline) of biomarkers indicating myocardial fibrosis
type 1 collagen telopeptide (ng/mL), aminoterminal propeptide of type I procollagen (ng/mL), aminoterminal propeptide of type III procollagen (ng/mL), matrix metalloproteinase2 (ng/mL), matrix metalloproteinase9 (ng/mL) at 1 and 6 months after AMI.
major adverse cardiac event
frequency of the reported cardiovascular events (defined as cardiogenic death, stroke, recurrent myocardial infarction, readmission on account of deterioration of congestive heart failure or unstable angina, target vessel revascularization)
6-minute walk test
A 6-minute walk test measures the distance patients can quickly walk in 6 minutes. (in meters)
New York Heart Association functional classification
I Cardiac disease, but no symptoms and no limitation in ordinary physical activity, e.g. no shortness of breath when walking, climbing stairs etc. II Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. III Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. IV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Seattle Angina Questionnaire score
The Seattle Angina Questionnaire is a valid and reliable instrument that measures five clinically important dimensions of health in patients with coronary artery disease (physical limitation, anginal stability, anginal frequency, treatment satisfaction, and disease perception). (in Units on a Scale).

Full Information

First Posted
August 10, 2015
Last Updated
August 31, 2016
Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02524964
Brief Title
Sodium Tanshinone IIA Sulfonate in Left Ventricular Remodeling Secondary to Acute Myocardial Infarction
Official Title
Effects of Sodium Tanshinone IIA Sulfonate on Left Ventricular Remodeling in Patients With ST-segment Elevation Myocardial Infarction Following Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Approximately 60 patients with ST-segment elevation myocardial infarction successfully treated with primary percutaneous coronary intervention will be enrolled and randomized to receive the sodium tanshinone IIA sulfonate in addition to standard therapy or the same volume/day of normal saline. The primary endpoint is the variation in LV end-diastolic volume index (LVEDVi) assessed with cardiac magnetic resonance imaging (MRI) at baseline and 6 months.
Detailed Description
The primary endpoint is to determine whether sodium tanshinone IIA sulfonate could prevent LV remodeling among patients with completely reperfused AMI after PCI, detected by 6 month change in LVEDVi measured using cardiac MRI when compared to placebo. Secondary endpoints will include cardiac MRI measures of variations in microvascular obstruction, defect size, ventricular wall motion score, wall thickening, global LV ejection fraction, ventricular volumes (LV end-systolic/ diastolic volume) and myocardial perfusion during the same interval. Furthermore, the investigators will determine the variation (change from baseline) of biomarkers indicating myocardial fibrosis (PICP, PIIINP, ICTP and MMPs) and NT-ProBNP at 1 and 6 months after AMI. Additional efficacy endpoints will include 6-minute walk test, New York Heart Association functional classification, Seattle Angina Questionnaire score and incidence of cardiovascular events (defined as cardiogenic death, stroke, recurrent myocardial infarction, readmission on account of deterioration of congestive heart failure or unstable angina, target vessel revascularization) at the 6-month follow-up will also be analyzed to evaluate the efficacy of sodium tanshinone IIA sulfonate treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Remodeling, Acute Myocardial Infarction
Keywords
left ventricular remodeling, cardiac magnetic resonance imaging, acute myocardial infarction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sodium tanshinone IIA sulfonate
Arm Type
Experimental
Arm Description
sodium tanshinone IIA sulfonate (80 mg q.d. for 7 days)
Arm Title
control
Arm Type
Sham Comparator
Arm Description
same volume/day of normal saline.
Intervention Type
Drug
Intervention Name(s)
sodium tanshinone IIA sulfonate
Other Intervention Name(s)
sodium tanshinone IIA sulfonate injection
Intervention Description
eligible participants were randomized to receive sodium tanshinone IIA sulfonate injection (drip 80 mg/day for 7 days immediately after PCI)
Intervention Type
Other
Intervention Name(s)
control
Other Intervention Name(s)
sodium chloride solution
Intervention Description
equivalent volume of sodium chloride solution
Primary Outcome Measure Information:
Title
left ventricular end-diastolic volume index
Description
The primary endpoint is to determine whether sodium tanshinone IIA sulfonate could prevent LV remodeling among patients with completely reperfused AMI after PCI, detected by 6 month change in left ventricular end-diastolic volume index (mL/m^2) measured using cardiac magnetic resonance imaging .
Time Frame
6 months
Secondary Outcome Measure Information:
Title
cardiac magnetic resonance imaging measures of LV remolding
Description
cardiac magnetic resonance imaging measures of variations in left ventricular end-systolic/ diastolic volume (mL) during the same interval.
Time Frame
6 months
Title
cardiac magnetic resonance imaging measures of microvascular obstruction
Description
cardiac magnetic resonance imaging measures of the frequency of delayed or absent wash-in of contrast agent into the infarct zone.
Time Frame
6 months
Title
variation (change from baseline) of biomarkers indicating myocardial fibrosis
Description
type 1 collagen telopeptide (ng/mL), aminoterminal propeptide of type I procollagen (ng/mL), aminoterminal propeptide of type III procollagen (ng/mL), matrix metalloproteinase2 (ng/mL), matrix metalloproteinase9 (ng/mL) at 1 and 6 months after AMI.
Time Frame
6 months
Title
major adverse cardiac event
Description
frequency of the reported cardiovascular events (defined as cardiogenic death, stroke, recurrent myocardial infarction, readmission on account of deterioration of congestive heart failure or unstable angina, target vessel revascularization)
Time Frame
1 and 6 months
Title
6-minute walk test
Description
A 6-minute walk test measures the distance patients can quickly walk in 6 minutes. (in meters)
Time Frame
6 months
Title
New York Heart Association functional classification
Description
I Cardiac disease, but no symptoms and no limitation in ordinary physical activity, e.g. no shortness of breath when walking, climbing stairs etc. II Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. III Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. IV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Time Frame
6 months
Title
Seattle Angina Questionnaire score
Description
The Seattle Angina Questionnaire is a valid and reliable instrument that measures five clinically important dimensions of health in patients with coronary artery disease (physical limitation, anginal stability, anginal frequency, treatment satisfaction, and disease perception). (in Units on a Scale).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.Aged 18 years or over and under 80 years; 2. First-time myocardial infarction on admission; 3. Presence of STEMI who has successfully coronary recanalization by PCI within 12 h after the symptom onset; 4. Willingness to provide informed consent prior to enrollment; 5. Patient is able to comply with all follow-up evaluation Exclusion Criteria: 1. Contraindications to performance of CMRI [pacemakers, implantable cardioverter/defibrillator devices, cardiac resynchronization therapy (CRT), claustrophobia, metal implants (joint prosthesis, et al), history of penetrative eye lesion]; 2. Previous myocardial infarction, arrhythmia (including atrial fibrillation or bundle brunch block), significant valvular disease, and hypertrophic cardiomyopathy; 3. Severe heart failure (NYHA cardiac function class IV or left ventricular ejection fraction≤30%) or cardiogenic shock; 4. Serious impairment of renal function (glomerular filtration rate ≤50 mL/min per 1.73 m2); 5. Hypohepatia (elevated of alanine aminotransferase and aspartate aminotransferase serum levels); 6. Severe coagulopathy prior to randomization; 7. Malignant tumors or other life-threatening diseases with limited life expectancy <1 year; 8. Significant neuropsychopathic condition precluding written informed consent; 9. Pregnant and lactating women; 10. Known radiographic contrast or sodium tanshinone IIA sulfonate allergy; 11. Be on therapy with immunosuppressants; 12. Currently participated in any other investigational therapeutic or device trial; 13. Clinical follow-up over the next half years not possible
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shuai mao, M.D.
Phone
86-20-81887233
Ext
32808
Email
maoshuaitcm@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
minzhouzhang zhang, M.D.
Organizational Affiliation
Guangdong Provincial Hospital of Traditional Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Guangdong Provincial Hospital of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minzhou Zhang, Dr.
Phone
86-20-81887233
Ext
32801
Email
minzhouzhang@yeah.net
First Name & Middle Initial & Last Name & Degree
Liheng Guo, Dr.
Phone
86-8187236
Ext
32907
Email
lihengguo1@yeah.net

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26482376
Citation
Mao S, Li X, Wang L, Yang PC, Zhang M. Rationale and Design of Sodium Tanshinone IIA Sulfonate in Left Ventricular Remodeling Secondary to Acute Myocardial Infarction (STAMP-REMODELING) Trial: A Randomized Controlled Study. Cardiovasc Drugs Ther. 2015 Dec;29(6):535-542. doi: 10.1007/s10557-015-6625-2.
Results Reference
derived

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Sodium Tanshinone IIA Sulfonate in Left Ventricular Remodeling Secondary to Acute Myocardial Infarction

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