Evaluation of C13 Breath Test for Upper Gastrointestinal Bleeding in Patients Who Need Double Antiplatelet After PCI

Acute Myocardial Infarction Clinical Trial

Official title:

Evaluation of C13 Breath Test for Upper Gastrointestinal Bleeding in Patients of Acute Myocardial Infarction Who Need Double Antiplatelet After PCI

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04012801
• Other study ID #: 2019-09
• Status: Active, not recruiting
• Start date: January 2015
• Est. completion date: July 2020

Study information

• Verified date: March 2020
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hp infection is closely related to upper gastrointestinal bleeding in patients who need dual-antiplatelet after PCI. Taking anti-Hp treatment has the effect of reducing bleeding risk. Thus, we propose a scientific hypothesis: the C13 breath test may be used to assess the risk of upper gastrointestinal bleeding in patients who need dual- antiplatelet after PCI.

Description:

Our study is to retrospectively analyze the clinical data of 1606 patients of acute myocardial infarction who need dual- antiplatelet after PCI.The diagnostic criteria for upper gastrointestinal bleeding is: 1.symptoms: digestive discomfort, such as abdominal pain, nausea, belching, acid reflux, etc.;2.mainly based on endoscopy examination, endoscopic examination showed that the stomach or duodenum showed spotted, linear or diffuse bleeding;3.the fecal examination:melena, tar-like stool, hematemesis, fecal occult blood, etc.The study was divided into two groups according to whether the C13 breath test was performed, and the C13 breath test component was the positive anti-HP treatment group and the non-anti-HP treatment group.And then compare the upper gastrointestinal bleeding rates of the above groups.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Years to 93 Years

Eligibility

Inclusion Criteria:

• The diagnosis of patients with coronary heart disease is based on the diagnostic criteria of ACA/AHA,the diagnostic criteria for upper gastrointestinal bleeding refer to the guidelines for the diagnosis and treatment of acute non-variceal upper gastrointestinal bleeding.

• In the hospital, all patientsI were treated with clopidogrel 300 mg or ticagrelor 180 mg before surgery, and C13 breath test was performed after surgery.

• All patients were treated with dual- antiplatelet.

• The clinical data of the included subjects were complete.

Exclusion Criteria:

• Patients with previous liver and kidney disease, Cr greater than 150 µmol / L, AST or ALT increased more than 2 times the normal value of patients.

• Patient with history of cerebrovascular disease.

• Patients with active gastrointestinal bleeding disease due to cirrhosis or other reasons before PCI.

• Patients with abnormal coagulation.

• Diabetic patients, diagnostic criteria for anemia: 8th edition of internal medicine, adult males with Hb less than 120g / L or RBC less than 4 × 10^12 / L, adult women with Hb less than 105g / L or RBC than 3.5 × 10^12 / L.

• Patients with incomplete medical records;7.Patient with pregnant.

• Patients with malignant tumors

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Gastrointestinal Hemorrhage
• Infarction
• Myocardial Infarction

Intervention

Diagnostic Test:
• C13 breath test
C13 breath test for patients of acute myocardial infarction who need dual- antiplatelet after PCI.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptoms of upper gastrointestinal bleeding	Number of participants with digestive discomfort, such as abdominal pain, nausea, belching, acid reflux, etc.	2019-12
Primary	endoscopy examination of upper gastrointestinal bleeding	Number of participants with spotted, linear or diffuse bleeding	2019-12
Primary	the fecal examination of upper gastrointestinal bleeding	Number of participants with melea, tar-like stool, hematemesis, fecal occult blood, etc.	2019-12