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

August 31, 2016 updated by: shuai Mao, Guangdong Provincial Hospital of Traditional Chinese Medicine

Effects of Sodium Tanshinone IIA Sulfonate on Left Ventricular Remodeling in Patients With ST-segment Elevation Myocardial Infarction Following Percutaneous Coronary Intervention

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Guangdong Provincial Hospital of Chinese Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • sodium tanshinone IIA sulfonate injection
Sham Comparator: control
same volume/day of normal saline.
Other: control
equivalent volume of sodium chloride solution
Other Names:
  • sodium chloride solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months
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.
6 months
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.
6 months
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.
6 months
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)
1 and 6 months
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 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Investigators

  • Study Director: minzhouzhang zhang, M.D., Guangdong Provincial Hospital of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (Estimate)

August 17, 2015

Study Record Updates

Last Update Posted (Estimate)

September 1, 2016

Last Update Submitted That Met QC Criteria

August 31, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2014-011-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Myocardial Infarction

Clinical Trials on sodium tanshinone IIA sulfonate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe