Acute Myocardial InfarctionNCT04012801
Evaluation of C13 Breath Test for Upper Gastrointestinal Bleeding in Patients Who Need Double Antiplatelet After PCI
An observational study of Acute Myocardial Infarction, run by Chongqing Medical University.
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. Read more about this study
- Who is it for?
- Ages 24 to 93 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- C13 breath test
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 93 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients of acute myocardial infarction who need dual- antiplatelet after PCI.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Evaluation of C13 Breath Test for Upper Gastrointestinal Bleeding in Patients of Acute Myocardial Infarction Who Need Double Antiplatelet After PCI
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.
Read the 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.
- Conditions
- Acute Myocardial Infarction
- Being tested
- C13 breath test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C13 breath testDiagnostic test
C13 breath test for patients of acute myocardial infarction who need dual- antiplatelet after PCI.
What is being measured
The primary outcome is the main question the study is designed to answer.
symptoms of upper gastrointestinal bleeding
Number of participants with digestive discomfort, such as abdominal pain, nausea, belching, acid reflux, etc.
Measured: 2019-12
endoscopy examination of upper gastrointestinal bleeding
Number of participants with spotted, linear or diffuse bleeding
Measured: 2019-12
the fecal examination of upper gastrointestinal bleeding
Number of participants with melea, tar-like stool, hematemesis, fecal occult blood, etc.
Measured: 2019-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study startJan 2015
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongying Zhang, Chongqing Medical University
- Investigators
- DZhang D Z, Associate Professor, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012801
- Sponsor's protocol ID
- 2019-09
- Status last verified
- Mar 2020
- First submitted
- 22 Jun 2019
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of C13 Breath Test for Upper Gastrointestinal Bleeding in Patients of Acute Myocardial Infarction Who Need Double Antiplatelet After PCI
- ClinicalTrials.gov ID
- NCT04012801
- Acronym / sponsor ID
- 2019-09
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 24 to 93 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients of acute myocardial infarction who need dual- antiplatelet after PCI.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C13 breath testC13 breath test for patients of acute myocardial infarction who need dual- antiplatelet after PCI. | Diagnostic test | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DZhang D Z, Associate Professor principal investigator
First Affiliated Hospital of Chongqing Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by Chongqing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptoms of upper gastrointestinal bleeding (time frame: 2019-12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.