Relationship of Helicobacter Pylori Eradication Therapy and Long-term Outcome in Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

Official title:

Beijing Tiantan Hospital,Capital Medical University.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317445
• Other study ID #: HPERINACS
• Status: Completed
• Phase: N/A
• First received: November 13, 2014
• Last updated: December 15, 2014
• Start date: January 2008
• Est. completion date: January 2013

Study information

• Verified date: December 2014
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: January 2013
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 73 Years

Eligibility

Inclusion Criteria:

• Patients were diagnosed acute coronary syndrome according to the 2012 ESC guidlines.

• All the patients took dual antiplatelet therapy after implanting drug eluting stent (DES) during hospitalization and had no any digestive symptoms.

Exclusion Criteria:

• Subjects who had suffered gastrointestinal bleeding within one week.

• Subjects had a history of gastrectomy, cardiac insufficiency, thyroid dysfunction, and any ongoing infections were eliminated.

• Patients with the use of antibiotics, bismuth, or sucralfate within one month and without impanting DES because of ACS during hospitalization were also excluded.

• Those who had gastrointestinal symptoms, such as acid reflux, heartburn, nausea, vomiting, stomach ache and diarrhea, or had a confirmed peptic ulcer with Hp infection were excluded because these patients may be taken gastroenterology treatment.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

References & Publications (10)

Budzynski J, Klopocka M, Bujak R, Swiatkowski M, Pulkowski G, Sinkiewicz W. Autonomic nervous function in Helicobacter pylori-infected patients with atypical chest pain studied by analysis of heart rate variability. Eur J Gastroenterol Hepatol. 2004 May;1 — View Citation

Fashner J, Gitu AC. Common Gastrointestinal Symptoms: dyspepsia and Helicobacter pylori. FP Essent. 2013 Oct;413:24-8. Review. — View Citation

Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K, Ohman M, Petrie MC, Sonntag F, Uva MS, Storey RF, Wijns W, Zahger D; ESC Committee for Practice Guidelines. ESC Guidelines for the management of acute coronary — View Citation

Lee SD. Notice of retraction of "The experience with Ritleng intubation system in patients with congenital nasolacrimal duct obstruction". J Chin Med Assoc 2004;67:344-8. J Chin Med Assoc. 2008 Jun;71(6):329. doi: 10.1016/S1726-4901(08)70133-3. — View Citation

Lee SY. Current progress toward eradicating Helicobacter pylori in East Asian countries: differences in the 2013 revised guidelines between China, Japan, and South Korea. World J Gastroenterol. 2014 Feb 14;20(6):1493-502. doi: 10.3748/wjg.v20.i6.1493. Rev — View Citation

Ng FH, Wong SY, Lam KF, Chang CM, Lau YK, Chu WM, Wong BC. Gastrointestinal bleeding in patients receiving a combination of aspirin, clopidogrel, and enoxaparin in acute coronary syndrome. Am J Gastroenterol. 2008 Apr;103(4):865-71. doi: 10.1111/j.1572-02 — View Citation

Roesler BM, Rabelo-Gonçalves EM, Zeitune JM. Virulence Factors of Helicobacter pylori: A Review. Clin Med Insights Gastroenterol. 2014 Mar 27;7:9-17. doi: 10.4137/CGast.S13760. eCollection 2014. Review. — View Citation

Rogha M, Nikvarz M, Pourmoghaddas Z, Shirneshan K, Dadkhah D, Pourmoghaddas M. Is helicobacter pylori infection a risk factor for coronary heart disease? ARYA Atheroscler. 2012 Spring;8(1):5-8. — View Citation

Vafaeimanesh J, Hejazi SF, Damanpak V, Vahedian M, Sattari M, Seyyedmajidi M. Association of Helicobacter pylori infection with coronary artery disease: is Helicobacter pylori a risk factor? ScientificWorldJournal. 2014 Jan 16;2014:516354. doi: 10.1155/20 — View Citation

Wright RS, Anderson JL, Adams CD, Bridges CR, Casey DE Jr, Ettinger SM, Fesmire FM, Ganiats TG, Jneid H, Lincoff AM, Peterson ED, Philippides GJ, Theroux P, Wenger NK, Zidar JP, Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the MACE among the three groups.	The Hp+ without eradication therapy had more MACE than Hp-positive patients with eradication therapy	January 1, 2008 to December 31, 2013, up to 6 years	Yes
Secondary	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.	January 1, 2008 to December 31, 2013, up to 6 years	Yes