Sodium Tanshinone IIA Sulfonate in Left Ventricular Remodeling Secondary to Acute Myocardial Infarction
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|ClinicalTrials.gov Identifier: NCT02524964|
Recruitment Status : Unknown
Verified August 2016 by shuai Mao, Guangdong Provincial Hospital of Traditional Chinese Medicine.
Recruitment status was: Recruiting
First Posted : August 17, 2015
Last Update Posted : September 1, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Left Ventricular Remodeling Acute Myocardial Infarction||Drug: sodium tanshinone IIA sulfonate Other: control||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||July 2017|
Experimental: sodium tanshinone IIA sulfonate
sodium tanshinone IIA sulfonate (80 mg q.d. for 7 days)
Drug: sodium tanshinone IIA sulfonate
eligible participants were randomized to receive sodium tanshinone IIA sulfonate injection (drip 80 mg/day for 7 days immediately after PCI)
Other Name: sodium tanshinone IIA sulfonate injection
Sham Comparator: control
same volume/day of normal saline.
equivalent volume of sodium chloride solution
Other Name: sodium chloride solution
- left ventricular end-diastolic volume index [ Time Frame: 6 months ]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 .
- cardiac magnetic resonance imaging measures of LV remolding [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]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 [ Time Frame: 1 and 6 months ]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 [ Time Frame: 6 months ]A 6-minute walk test measures the distance patients can quickly walk in 6 minutes. (in meters)
- New York Heart Association functional classification [ Time Frame: 6 months ]
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 [ Time Frame: 6 months ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02524964
|Contact: shuai mao, M.D.||86-20-81887233 ext email@example.com|
|Study Director:||minzhouzhang zhang, M.D.||Guangdong Provincial Hospital of Traditional Chinese Medicine|