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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
shuai Mao, Guangdong Provincial Hospital of Traditional Chinese Medicine

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.


Condition or disease Intervention/treatment Phase
Left Ventricular Remodeling Acute Myocardial Infarction Drug: sodium tanshinone IIA sulfonate Other: control Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
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.
Other: control
equivalent volume of sodium chloride solution
Other Name: sodium chloride solution




Primary Outcome Measures :
  1. 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 .


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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)

  5. 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)

  6. 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.


  7. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: shuai mao, M.D. 86-20-81887233 ext 32808 maoshuaitcm@hotmail.com

Locations
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China, Guangdong
Guangdong Provincial Hospital of Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Minzhou Zhang, Dr.    86-20-81887233 ext 32801    minzhouzhang@yeah.net   
Contact: Liheng Guo, Dr.    86-8187236 ext 32907    lihengguo1@yeah.net   
Sponsors and Collaborators
Guangdong Provincial Hospital of Traditional Chinese Medicine
Investigators
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Study Director: minzhouzhang zhang, M.D. Guangdong Provincial Hospital of Traditional Chinese Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: shuai Mao, Department of Critical Care Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02524964    
Other Study ID Numbers: B2014-011-01
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by shuai Mao, Guangdong Provincial Hospital of Traditional Chinese Medicine:
left ventricular remodeling
cardiac magnetic resonance imaging
acute myocardial infarction
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ventricular Remodeling
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Tanshinone
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anticoagulants
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors