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

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Treatments: Tanshinone

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