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

NCT ID: NCT02317445

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

472 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Acute Coronary Syndrome

Keywords

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helicobacter pylori eradication therapy major adverse cardiac events long-term outcome To explore the significance of Hp eradication therapy in preventing major adverse cardiac events (MACE) and upper gastrointestinal bleeding (UGIB).

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

73 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Buxing Chen

Beijing Tiantan Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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;16(5):451-7. doi: 10.1097/00042737-200405000-00003.

Reference Type RESULT
PMID: 15097036 (View on PubMed)

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

Reference Type RESULT
PMID: 24124704 (View on PubMed)

Roesler BM, Rabelo-Goncalves 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.

Reference Type RESULT
PMID: 24833944 (View on PubMed)

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.1572-0241.2007.01715.x. Epub 2008 Jan 2.

Reference Type RESULT
PMID: 18177451 (View on PubMed)

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. No abstract available.

Reference Type RESULT
PMID: 18567567 (View on PubMed)

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.

Reference Type RESULT
PMID: 23056092 (View on PubMed)

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: 10.1155/2014/516354. eCollection 2014.

Reference Type RESULT
PMID: 24574896 (View on PubMed)

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.

Reference Type RESULT
PMID: 24587624 (View on PubMed)

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 syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2011 Dec;32(23):2999-3054. doi: 10.1093/eurheartj/ehr236. Epub 2011 Aug 26. No abstract available.

Reference Type RESULT
PMID: 21873419 (View on PubMed)

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 WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS. 2011 ACCF/AHA focused update of the Guidelines for the Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction (updating the 2007 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines developed in collaboration with the American College of Emergency Physicians, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2011 May 10;57(19):1920-59. doi: 10.1016/j.jacc.2011.02.009. Epub 2011 Mar 28. No abstract available.

Reference Type RESULT
PMID: 21450428 (View on PubMed)

Other Identifiers

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HPERINACS

Identifier Type: -

Identifier Source: org_study_id