the Effect of Danhong Injection on Microcirculation in the Treatment of Patients With STEMI After the PTCA Surgery.

NCT02158559 | Unknown Phase 4 DMC

• 1 other identifier: DH-140318-01
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study focused on the effect of Danhong injection on microcirculation in the treatment of patients with STEMI(ST-elevation myocardical infarction) after the PTCA surgery.

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• After 7 days surgery used magnetic resonance assessed myocardial perfusion and myocardial function.

  1 week

Study Arms (2)

Danhong Injection

EXPERIMENTAL

Danhong injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;

Drug: Danhong Injection

Normal Saline

PLACEBO COMPARATOR

0.9% sodium chloride solution 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;

Drug: Normal Saline

Interventions

Danhong Injection DRUG

Danhong injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;

Danhong Injection

Normal Saline DRUG

0.9% sodium chloride solution 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;

Normal Saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically definite or laboratory-supported diagnosis of STEMI ,with the indication of PTCA surgery.
• ≤Age≤75;
• Agreed to join in the study and signed the inform consent form.

You may not qualify if:

• Cardiogenic shock , Killip III-IV degree , papillary muscle rupture , septal perforation , episodes of ventricular tachycardia and ventricular fibrillation after electrical cardioversion , temporary pacemaker implanted AVB III degree.
• Past history of PCI and CABG
• Acute or chronic infectious diseases(for example severe pneumonia);
• Recent history of hemorrhagic stroke(within six months)
• Combined with liver and kidney dysfunction;
• History of valvular heart disease;
• Congenital heart disease or Pulmonary hypertension;
• All kinds of history of cardiomyopathy;
• Bleeding and other thrombotic diseases;
• Severe anemia , thrombocytopenia , Other diseases of the blood system;
• Cancer , Autoimmune disease , All kinds of the patients who use the glucocorticoid and immunosuppressor;
• Menstrual period women, pregnant women and lactating women, pregnancy test positive or recent family planning.

Sponsors & Collaborators

• Beijing Bozhiyin T&S Co., Ltd.: lead

MeSH Terms

Conditions

Myocardial Infarction

Interventions

danhong; Saline Solution

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 9, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2015
• Last Updated: June 9, 2014

Record last verified: 2014-06