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Clinical study on cardiovascular risk associated with defecation in STEMI patients treated with Biantong capsule

Clinical study on cardiovascular risk associated with defecation in patients of acute ST-segment elevation myocardial infarction treated with Biantong capsule

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017347
Enrollment
Unknown
Registered
2018-07-25
Start date
2018-08-06
Completion date
Unknown
Last updated
2018-07-31

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

Conditions

acute ST-segment elevation myocardial infarction

Interventions

Study group:Biantong capsule
Control group:Biantong capsule mimetic agent

Sponsors

Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age >18 years male and female; 2. Conform to the criteria for the diagnosis of acute ST segment elevation myocardial infarction: myocardial ischemia symptoms for 30 minutes or more, electrocardiogram shows at least two leads of ST-elevation > 0.05 mv in the adjacent two chest lead or > 0.1 mv in the body leads, or new left bundle branch block; 3. The time from onset to admission is less than 3 days; 4. Voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Constipation with dry feces and laborious defecation at least 6 months before admission; 2. Patients with diarrhea within 7 days of admission; 3. Patients who have used drugs to treat constipation for nearly 2 weeks; 4. Patients with known organic lesions of the colon and rectum and chronic functional intestinal diseases; 5. Patients with known severe cerebrovascular disease or other neuropsychiatric disorders, leading to a lack or loss of autonomic bowel control; 6. Patients with known severe liver dysfunction (ALT or AST levels more than 3 times higher than the upper limit of normal values), renal insufficiency (GFR<30ml/min), moderate to severe chronic obstructive pulmonary disease, and pulmonary hypertension; 7. Women known or preparing for pregnancy or lactation; 8. People who are known to be allergic or have severe adverse reactions to the capsule and its contents; 9. Have participated in other clinical studies within 3 months prior to the study or are currently participating in other clinical researchers; 10. According to the judgment of the researcher, patients who cannot complete the study or who cannot comply with the requirements of the study.

Design outcomes

Primary

MeasureTime frame
Complex cardiovascular endpoint events;

Secondary

MeasureTime frame
Area under the curve(AUC) of myocardial oxygen consumption;Area under the curve(AUC) of average value of the change in ST segment;Cardiovascular death + recurrent nonfatal myocardial infarction;All-cause death;

Countries

China

Contacts

Public ContactShaoping Nie

Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University

spnie@126.com+86 010-84005253

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026