An observational study in Acute Coronary Syndrome, sponsored by Capital Medical University. Completed. Open to participants aged 50 Years to 73 Years. Per ClinicalTrials.gov, last updated 2014-12-16.
Sponsored by Capital Medical University · Observational
Objective: To investigate the relationship between Helicobacter pylori (Hp) infection and the prognosis of acute coronary syndrome (ACS) in a Chinese population and to explore the significance of Hp eradication therapy in preventing major adverse cardiac events (MACE) and upper gastrointestinal bleeding (UGIB) in patients on dual antiplatelet treatment. Methods: To analyze 472 ACS patients with drug-eluting stent (DES) implantation from January 1, 2008 to December 31, 2010 in the department of cardiology at Beijing Mentougou District Hospital. Patients were divided into three groups: Group 1, the Hp-negative patients (Hp-); Group 2, the Hp-positive patients with eradication therapy (Hp+ Therapy); and Group 3, the Hp-positive patients without eradication therapy (Hp+ No Therapy). All patients took 13C urea breath test, high sensitive C-reactive protein (hs-CRP)，homocysteine (HCY) and other biochemical indicators. The investigators explored the correlations of Hp eradication therapy with MACE (including recurrent myocardial infarction, revascularization and death) and UGIB after 3 to 5 years of follow-up using survival analysis.
This study is a single-center and random analysis. The consecutive hospitalized patients with ACS at Beijing Mentougou District Hospital from January 1, 2008 to December 31, 2010 were enrolled. Figure 1 is a flow diagram of the trial. There were 259 males (54.9%) and 213 females (45.1%) with an average age of 61.1 ± 11.0 years. Patient's history, physical examination, and laboratory results were recorded. All patients were divided into the Hp-negative group (Hp-, group 1.) and the Hp-positive group (Hp+). The Hp+ group were randomly divided into two groups: Group 2, the Hp+ with eradication therapy (Hp+ Therapy); and Group 3, the Hp+ without eradication therapy (Hp+No Therapy).
1,492 studies on the registry are indexed under Acute Coronary Syndrome; 270 are open to participants now.
This study's enrollment of 472 is close to the median of 500 across 579 observational studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Capital Medical University is the lead sponsor of 293 studies on the registry; 91 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study is a single-center and random analysis. The consecutive hospitalized patients with ACS at Beijing Mentougou District Hospital from January 1, 2008 to December 31, 2010 were enrolled. Figure 1 is a flow diagram of the trial. There were 259 males (54.9%) and 213 females (45.1%) with an average age of 61.1 ± 11.0 years. Patient's history, physical examination, and laboratory results were recorded. All patients were divided into the Hp-negative group (Hp-, group 1.) and the Hp-positive group (Hp+). The Hp+ group were randomly divided into two groups: Group 2, the Hp+ with eradication therapy (Hp+ Therapy); and Group 3, the Hp+ without eradication therapy (Hp+No Therapy).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Comparison of the MACE among the three groups.
The Hp+ without eradication therapy had more MACE than Hp-positive patients with eradication therapy
Time frame: January 1, 2008 to December 31, 2013, up to 6 years
Comparison of the upper gastrointestinal bleeding among the three groups.
The Hp-infected patients without eradication therapy had more UGIB than Hp-positive patients with eradication therapy.
Time frame: January 1, 2008 to December 31, 2013, up to 6 years
No study locations are listed for this record.
The record gives a start of Jan 2008, a primary completion of Dec 2010 and a completion of Jan 2013. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.