Cardiovascular Diseases Clinical Trial
— HELP-MIOfficial title:
HELicobacter Pylori Screening to Prevent Gastrointestinal Bleeding in Patients With Acute Myocardial Infarction Trial Based on the SWEDEHEART Registry (HELP-SWEDEHEART)
Background: Potent antithrombotic therapy has improved prognosis for patients with acute myocardial infarction (MI) significantly, however, at a price of increased bleeding risk. Helicobacter pylori (H. pylori) infection commonly causes upper gastrointestinal bleeding (UGIB). If systematic screening for H. pylori and subsequent eradication therapy significantly reduces the risk of UGIB and improves outcomes is unknown. Study design: A cluster randomized, cross-over, registry-based clinical trial using nationwide Swedish registries for patient enrollment and data collection. Population: Patients hospitalized for MI at up to 40 hospitals across Sweden. Regional PCI networks comprise 18 clusters. Clusters will be randomized to H. pylori screening or no screening for 1 year after which cross-over to the opposite strategy for 1 year is followed by 1-year follow-up. Intervention: All MI patients will be routinely screened for H. pylori. Patients diagnosed with active H. pylori infection will receive eradication therapy. All follow-up by data collection from national registries. Controls: Standard clinical practice. Data will be collected from national registries. Outcome: Primary outcome is the incidence of hospitalization for UGIB. Secondary outcomes include mortality (all-cause, cardiovascular), cardiovascular endpoints (rehospitalization for MI, heart failure or stroke), or UGIB requiring blood transfusion.
Status | Recruiting |
Enrollment | 22000 |
Est. completion date | January 17, 2030 |
Est. primary completion date | January 17, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 - Registered in SWEDEHEART as admitted at an active study site and with a discharge diagnosis of myocardial infarction including ICD-10 code I21 or I22. Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
Sweden | Södra Älvsborg Hospital | Borås | |
Sweden | Eskilstuna Hospital | Eskilstuna | |
Sweden | Falun Hospital | Falun | |
Sweden | Gävle Hospital | Gävle | |
Sweden | Östra Hospital | Göteborg | |
Sweden | Sahlgrenska University Hospital | Göteborg | |
Sweden | Halmstad Hospital | Halmstad | |
Sweden | Helsingborg Hospital | Helsingborg | |
Sweden | Ryhov Hospital | Jönköping | |
Sweden | Karlskrona Hospital | Karlskrona | |
Sweden | Köping Hospital | Köping | |
Sweden | Kristianstad Hospital | Kristianstad | |
Sweden | Kungälv Hospital | Kungälv | |
Sweden | Lidköping Hospital | Lidköping | |
Sweden | Linköping University Hospital | Linköping | |
Sweden | Skåne University Hospital Lund | Lund | |
Sweden | Skåne University Hospital Malmö | Malmö | |
Sweden | Mölndal Hospital | Mölndal | |
Sweden | Mora Hospital | Mora | |
Sweden | Motala Hospital | Motala | |
Sweden | Vrinnevisjukhuset | Norrköping | |
Sweden | Norrtälje Hospital | Norrtälje | |
Sweden | Nyköping Hospital | Nyköping | |
Sweden | Örebro University Hospital | Örebro | |
Sweden | Sunderby Hospital | Södra Sunderbyn | |
Sweden | Danderyds University Hospital | Stockholm | |
Sweden | Karolinska University Hospital Huddinge | Stockholm | |
Sweden | Karolinska University Hospital Solna | Stockholm | |
Sweden | Sankt Görans Hospital | Stockholm | |
Sweden | Södersjukhuset | Stockholm | |
Sweden | Norra Älvsborgs Länssjukhus | Trollhättan | |
Sweden | Norrland University Hospital | Umeå | |
Sweden | Uppsala University Hospital | Uppsala | |
Sweden | Varberg Hospital | Varberg | |
Sweden | Västerås Hospital | Västerås |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Region Stockholm, Swedish Heart Lung Foundation, The Swedish Research Council |
Sweden,
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Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol. 2017 Feb;112(2):212-239. doi: 10.1038/ajg.2016.563. Epub 2017 Jan 10. Erratum In: Am J Gastroenterol. 2018 Jul;113(7):1102. — View Citation
Eikelboom JW, Connolly SJ, Bosch J, Shestakovska O, Aboyans V, Alings M, Anand SS, Avezum A, Berkowitz SD, Bhatt DL, Cook-Bruns N, Felix C, Fox KAA, Hart RG, Maggioni AP, Moayyedi P, O'Donnell M, Ryden L, Verhamme P, Widimsky P, Zhu J, Yusuf S. Bleeding a — View Citation
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Lindholm D, Sarno G, Erlinge D, Svennblad B, Hasvold LP, Janzon M, Jernberg T, James SK. Combined association of key risk factors on ischaemic outcomes and bleeding in patients with myocardial infarction. Heart. 2019 Aug;105(15):1175-1181. doi: 10.1136/he — View Citation
Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group — View Citation
Ng JC, Yeomans ND. <em>Helicobacter pylori</em> infection and the risk of upper gastrointestinal bleeding in low dose aspirin users: systematic review and meta-analysis. Med J Aust. 2018 Sep 1;209(7):306-311. doi: 10.5694/mja17.01274. — View Citation
Sarajlic P, Simonsson M, Jernberg T, Back M, Hofmann R. Incidence, associated outcomes, and predictors of upper gastrointestinal bleeding following acute myocardial infarction: a SWEDEHEART-based nationwide cohort study. Eur Heart J Cardiovasc Pharmacothe — View Citation
Sarri GL, Grigg SE, Yeomans ND. Helicobacter pylori and low-dose aspirin ulcer risk: A meta-analysis. J Gastroenterol Hepatol. 2019 Mar;34(3):517-525. doi: 10.1111/jgh.14539. Epub 2018 Dec 17. — View Citation
Warme J, Sundqvist M, Mars K, Aladellie L, Pawelzik SC, Erlinge D, Jernberg T, James S, Hofmann R, Back M. Helicobacter pylori screening in clinical routine during hospitalization for acute myocardial infarction. Am Heart J. 2021 Jan;231:105-109. doi: 10. — View Citation
Xu Z, Li J, Wang H, Xu G. Helicobacter pylori infection and atherosclerosis: is there a causal relationship? Eur J Clin Microbiol Infect Dis. 2017 Dec;36(12):2293-2301. doi: 10.1007/s10096-017-3054-0. Epub 2017 Jul 27. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | CCS | Symptoms of angina and functional status (CCS class) at 2 months post index hospital admittance | 2 months | |
Other | NYHA | Symptoms of dyspnea and functional status (NYHA class) at 2 months post index hospital admittance | 2 months | |
Other | NYHA | Symptoms of dyspnea and functional status (NYHA class) at 12 months post index hospital admittance | 12 months | |
Other | CCS | Symptoms of angina and functional status (CCS class) at 12 months post index hospital admittance | 12 months | |
Other | EQ-5D | Health-related quality of life by EQ-5D at 12 months post index hospital admittance | 12 months | |
Other | EQ-5D | Health-related quality of life by EQ-5D at 2 months post index hospital admittance | 2 months | |
Other | Health care costs | Cost estimation with regard to consumed care | 1 year | |
Other | Health care costs | Cost estimation with regard to consumed care | 5 years | |
Other | Health care costs | Cost estimation with regard to consumed care | 10 years | |
Primary | Upper gastrointestinal bleeding (UGIB) | Time from index hospital admittance to UGIB | 1-2 years of follow-up | |
Secondary | Net Adverse Clinical Events (NACE) | Time from index hospital admittance to all-cause death, UGIB, rehospitalization with MI, hospitalization for HF or stroke (NACE) | 1 year | |
Secondary | Net Adverse Clinical Events (NACE) | Time from index hospital admittance to all-cause death, UGIB, rehospitalization with MI, hospitalization for HF or stroke (NACE) | 1-2 years of follow-up | |
Secondary | Net Adverse Clinical Events (NACE) | Time from index hospital admittance to all-cause death, UGIB, rehospitalization with MI, hospitalization for HF or stroke (NACE) | 1-3 years of follow-up | |
Secondary | Net Adverse Clinical Events (NACE) | Time from index hospital admittance to all-cause death, UGIB, rehospitalization with MI, hospitalization for HF or stroke (NACE) | 5 years | |
Secondary | Net Adverse Clinical Events (NACE) | Time from index hospital admittance to all-cause death, UGIB, rehospitalization with MI, hospitalization for HF or stroke (NACE) | 10 years | |
Secondary | Major Adverse Events (Bleeding) | Time from index hospital admittance to all-cause death or hospitalization for UGIB | 1 year | |
Secondary | Major Adverse Events (Bleeding) | Time from index hospital admittance to all-cause death or hospitalization for UGIB | 1-2 years | |
Secondary | Major Adverse Events (Bleeding) | Time from index hospital admittance to all-cause death or hospitalization for UGIB | 1-3 years | |
Secondary | Major Adverse Events (Bleeding) | Time from index hospital admittance to all-cause death or hospitalization for UGIB | 5 years | |
Secondary | Major Adverse Events (Bleeding) | Time from index hospital admittance to all-cause death or hospitalization for UGIB | 10 years | |
Secondary | Major Adverse Cardiac or Cerebrovascular Events (MACCE) 1 | Time from index hospital admittance to all-cause death, rehospitalization with MI, or hospitalization for HF, or stroke (MACCE 1) | 1 year | |
Secondary | Major Adverse Cardiac or Cerebrovascular Events (MACCE) 1 | Time from index hospital admittance to all-cause death, rehospitalization with MI, or hospitalization for HF, or stroke (MACCE 1) | 1-2 years of follow-up | |
Secondary | Major Adverse Cardiac or Cerebrovascular Events (MACCE) 1 | Time from index hospital admittance to all-cause death, rehospitalization with MI, or hospitalization for HF, or stroke (MACCE 1) | 1-3 years of follow-up | |
Secondary | Major Adverse Cardiac or Cerebrovascular Events (MACCE) 1 | Time from index hospital admittance to all-cause death, rehospitalization with MI, or hospitalization for HF, or stroke (MACCE 1) | 5 years | |
Secondary | Major Adverse Cardiac or Cerebrovascular Events (MACCE) 1 | Time from index hospital admittance to all-cause death, rehospitalization with MI, or hospitalization for HF, or stroke (MACCE 1) | 10 years | |
Secondary | Major Adverse Cardiac or Cerebrovascular Events (MACCE) 2 | Time from index hospital admittance to CV death, rehospitalization with MI, or hospitalization for HF, or stroke (MACCE 2) | 1 year | |
Secondary | Major Adverse Cardiac or Cerebrovascular Events (MACCE) 2 | Time from index hospital admittance to CV death, rehospitalization with MI, or hospitalization for HF, or stroke (MACCE 2) | 1-2 years | |
Secondary | Major Adverse Cardiac or Cerebrovascular Events (MACCE) 2 | Time from index hospital admittance to CV death, rehospitalization with MI, or hospitalization for HF, or stroke (MACCE 2) | 1-3 years | |
Secondary | Major Adverse Cardiac or Cerebrovascular Events (MACCE) 2 | Time from index hospital admittance to CV death, rehospitalization with MI, or hospitalization for HF, or stroke (MACCE 2) | 5 years | |
Secondary | Major Adverse Cardiac or Cerebrovascular Events (MACCE) 2 | Time from index hospital admittance to CV death, rehospitalization with MI, or hospitalization for HF, or stroke (MACCE 2) | 10 years | |
Secondary | All-cause death | Time from index hospital admittance to all-cause death | 1 year | |
Secondary | All-cause death | Time from index hospital admittance to all-cause death | 1-2 years of follow-up | |
Secondary | All-cause death | Time from index hospital admittance to all-cause death | 1-3 years of follow-up | |
Secondary | All-cause death | Time from index hospital admittance to all-cause death | 5 years | |
Secondary | All-cause death | Time from index hospital admittance to all-cause death | 10 years | |
Secondary | Cardiovascular death | Time from index hospital admittance to cardiovascular death | 1 year | |
Secondary | Cardiovascular death | Time from index hospital admittance to cardiovascular death | 1-2 years of follow-up | |
Secondary | Cardiovascular death | Time from index hospital admittance to cardiovascular death | 1-3 years of follow-up | |
Secondary | Cardiovascular death | Time from index hospital admittance to cardiovascular death | 5 years | |
Secondary | Cardiovascular death | Time from index hospital admittance to cardiovascular death | 10 years | |
Secondary | Rehospitalization with myocardial infarction | Time from index hospital admittance to rehospitalization with myocardial infarction | 1 year | |
Secondary | Rehospitalization with myocardial infarction | Time from index hospital admittance to rehospitalization with myocardial infarction | 1-2 years of follow-up | |
Secondary | Rehospitalization with myocardial infarction | Time from index hospital admittance to rehospitalization with myocardial infarction | 1-3 years of follow-up | |
Secondary | Rehospitalization with myocardial infarction | Time from index hospital admittance to rehospitalization with myocardial infarction | 5 years | |
Secondary | Rehospitalization with myocardial infarction | Time from index hospital admittance to rehospitalization with myocardial infarction | 10 years | |
Secondary | Rehospitalization for heart failure | Time from index hospital admittance to rehospitalization for heart failure | 1 years | |
Secondary | Rehospitalization for heart failure | Time from index hospital admittance to rehospitalization for heart failure | 1-2 years of follow-up | |
Secondary | Rehospitalization for heart failure | Time from index hospital admittance to rehospitalization for heart failure | 1-3 years of follow-up | |
Secondary | Rehospitalization for heart failure | Time from index hospital admittance to rehospitalization for heart failure | 5 years | |
Secondary | Rehospitalization for heart failure | Time from index hospital admittance to rehospitalization for heart failure | 10 years | |
Secondary | Rehospitalization for stroke | Time from index hospital admittance to rehospitalization for stroke | 1 year | |
Secondary | Rehospitalization for stroke | Time from index hospital admittance to rehospitalization for stroke | 1-2 years of follow-up | |
Secondary | Rehospitalization for stroke | Time from index hospital admittance to rehospitalization for stroke | 1-3 years of follow-up | |
Secondary | Rehospitalization for stroke | Time from index hospital admittance to rehospitalization for stroke | 5 years | |
Secondary | Rehospitalization for stroke | Time from index hospital admittance to rehospitalization for stroke | 10 years | |
Secondary | UGIB requiring blood transfusion | Time from index hospital admittance to UGIB requiring blood transfusion | 1 year | |
Secondary | UGIB requiring blood transfusion | Time from index hospital admittance to UGIB requiring blood transfusion | 1-2 years of follow-up | |
Secondary | UGIB requiring blood transfusion | Time from index hospital admittance to UGIB requiring blood transfusion | 1-3 years of follow-up | |
Secondary | UGIB requiring blood transfusion | Time from index hospital admittance to UGIB requiring blood transfusion | 5 years | |
Secondary | UGIB requiring blood transfusion | Time from index hospital admittance to UGIB requiring blood transfusion | 10 years | |
Secondary | Upper gastrointestinal bleeding (UGIB) | Time from index hospital admittance to UGIB | 1 year | |
Secondary | Upper gastrointestinal bleeding (UGIB) | Time from index hospital admittance to UGIB | 1-3 years | |
Secondary | Upper gastrointestinal bleeding (UGIB) | Time from index hospital admittance to UGIB | 5 years | |
Secondary | Upper gastrointestinal bleeding (UGIB) | Time from index hospital admittance to UGIB | 10 years |
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