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出境医 / 临床实验 / Evaluation of C13 Breath Test for Upper Gastrointestinal Bleeding in Patients Who Need Double Antiplatelet After PCI

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

Study Description
Brief 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.

Condition or disease Intervention/treatment
Acute Myocardial Infarction Diagnostic Test: C13 breath test

Detailed 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.
Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Evaluation of C13 Breath Test for Upper Gastrointestinal Bleeding in Patients of Acute Myocardial Infarction Who Need Double Antiplatelet After PCI
Actual Study Start Date : January 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. symptoms of upper gastrointestinal bleeding [ Time Frame: 2019-12 ]
    Number of participants with digestive discomfort, such as abdominal pain, nausea, belching, acid reflux, etc.

  2. endoscopy examination of upper gastrointestinal bleeding [ Time Frame: 2019-12 ]
    Number of participants with spotted, linear or diffuse bleeding

  3. the fecal examination of upper gastrointestinal bleeding [ Time Frame: 2019-12 ]
    Number of participants with melea, tar-like stool, hematemesis, fecal occult blood, etc.


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date June 22, 2019
First Posted Date July 9, 2019
Last Update Posted Date March 4, 2020
Actual Study Start Date January 2015
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 4, 2019)
  • symptoms of upper gastrointestinal bleeding [ Time Frame: 2019-12 ]
    Number of participants with digestive discomfort, such as abdominal pain, nausea, belching, acid reflux, etc.
  • endoscopy examination of upper gastrointestinal bleeding [ Time Frame: 2019-12 ]
    Number of participants with spotted, linear or diffuse bleeding
  • the fecal examination of upper gastrointestinal bleeding [ Time Frame: 2019-12 ]
    Number of participants with melea, tar-like stool, hematemesis, fecal occult blood, etc.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of C13 Breath Test for Upper Gastrointestinal Bleeding in Patients Who Need Double Antiplatelet After PCI
Official Title Evaluation of C13 Breath Test for Upper Gastrointestinal Bleeding in Patients of Acute Myocardial Infarction Who Need Double Antiplatelet After PCI
Brief 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.
Detailed 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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients of acute myocardial infarction who need dual- antiplatelet after PCI.
Condition Acute Myocardial Infarction
Intervention Diagnostic Test: C13 breath test
C13 breath test for patients of acute myocardial infarction who need dual- antiplatelet after PCI.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: July 4, 2019) 		1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 24 Years to 93 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04012801
Other Study ID Numbers 2019-09
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dongying Zhang, Chongqing Medical University
Study Sponsor Chongqing Medical University
Collaborators Not Provided
Investigators
Principal Investigator: DZhang D Z, Associate Professor First Affiliated Hospital of Chongqing Medical University
PRS Account Chongqing Medical University
Verification Date March 2020

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