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

A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of the Effect of Danhong Injection on Microcirculation in the Treatment of Patients With STEMI(ST- Elevation Myocardical Infarction) After the PTCA Surgery.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02158559

Acronym

Danhong

Enrollment

180

Registered

2014-06-09

Start date

2014-03-31

Completion date

Unknown

Last updated

2014-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

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.

Detailed description

Research Topic. * A randomized, double-blind, placebo-controlled, multi-center clinical trial of the effect of Danhong Injection on microcirculation in the treatment of patients with STEMI(ST- elevation myocardical infarction) after the PTCA surgery. Research Purpose. * 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. Research design. * A randomized, double-blind, placebo-controlled, multi-center clinical trial.

Interventions

DRUGDanhong Injection

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

DRUGNormal Saline

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;

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Clinically definite or laboratory-supported diagnosis of STEMI ,with the indication of PTCA surgery. * 18≤Age≤75; * Agreed to join in the study and signed the inform consent form.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
After 7 days surgery used magnetic resonance assessed myocardial perfusion and myocardial function.	1 week

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026