Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371098
Status:
COMPLETED
Last Update Posted:
2007-10-23
First Post:
2006-08-31
Brief Title:
Influenza Vaccination in Prevention From Acute Coronary Events in Coronary Artery Disease - FLUCAD Study
Sponsor:
National Institute of Cardiology Warsaw Poland
Organization:
National Institute of Cardiology Warsaw Poland
Study Overview
Official Title:
Prospective Randomized Double-Blind Placebo Controlled Study on Influenza Vaccination in Prevention From Coronary Events in Patients With Coronary Artery Disease Confirmed by Angiography
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Influenza vaccination is recommended in patients pts with cardiovascular disease however there is a shortage of clinical studies proving its protective effect on clinical course of coronary artery disease CAD The aim of the study was to evaluate the effect of influenza vaccination on the incidence of coronary events in pts with CAD confirmed by coronary angiography
Detailed Description:
A possible relation between influenza and higher mortality from cardiovascular problems was first noticed in early nineteen hundreds after epidemics in Europe and United States were discovered 1 In the last decade many studies implicating an important role of inflammation and infection Herpes virus Chlamydia pneumoniae Helicobacter pylori in development and progression of atherosclerosis 23 and markers of inflammation like hs-CRP fibrinogen have become new independent cardiovascular risk factors 4
Many general physicians now recommend influenza vaccination in patients with coronary artery disease CAD despite shortage of studies proving its protective effect on clinical course of CAD In literature we found only a few reports exploring the hypothesis that influenza vaccination might reduce the incidence of myocardial infarction MI and acute coronary syndromes ACS
Naghavi et all in retrospective case- control study of 218 patients with chronic coronary disease reported that influenza vaccination was strongly associated with freedom from new MI during the same influenza season OR 033 95 CI 013 to082 p0017 5 Gurfinkiel et all evaluated in prospective single- blind Fluvacs study that preventive impact of vaccination on subsequent ischemic events at 6 months follow-up Study group consisted of 301 patients after coronary angioplasty PCI The first primary outcome- cardiovascular death occurred in 2 in vaccine group compared with 8 in the control group p001 and triple composite end point death myocardial infarction and hospitalization from ischemia occurred in 11 in vaccine group vs 23 in controls p00009 6 In the contrary Jackson et all in largest study of 1378 survivors of first MI in long median 23 year follow-up didnt find the benefit of influenza vaccine on the protection against recurrent coronary events 7
The aim of our study is to evaluate the influence of influenza vaccination on the incidence of cardiac events cardiovascular death myocardial infarction acute coronary syndromes coronary revascularization and hospitalizations from ischemia in patients with angiographically confirmed coronary disease
References
1 Collins SD Excess mortality from causes other that influenza and pneumonia during influenza epidemics Public Health Rep 1932472159-80
2 Sorlie PD Adam E Melnick SL et al Cytomegalovirusherpesvirus and carotid atherosclerosis the ARIC Study J Med Virol 19944233-37
3 Zhou YF Wanishsawad C Epstein SE Chlamydia pneumonia-induced transaction of cytomegalovirus potential synergy of infectious agents in the pathogenesis of atherosclerosis J Am Coll Cardiol 199933suppl A260A
4 Toss H Lindahl B Siegbahn A Wallentin L Frisc study group Prognostic Influence of Increased Fibrinogen and C- reactive Protein Levels in Unstable Coronary Artery Disease Circulation 1997 96 4304- 4210
5 Naghavi M Barlas Z Siadaty S Nagiub S Madjid M Casscells W Association of influenza vaccination and reduced risk of myocardial infarction Circulation 2000 1023039-3045
6 Gurfinkel EP Leon de la Fuente R Mendiz O Mautner B For the FLUVACS Study Group Influenza vaccine pilot study in acute coronary syndromes and planned percutaneous coronary interventions The FLU vaccination acute coronary syndromes FLUVACS Study Circulation 20021052143-2147
7 Jackson LA Heckbert SR Psaty BM Malais D Barlow WE Thompson WW Vaccine Safety Datalink Study Group Influenza vaccination is not associated with a reduction in the risk of recurrent coronary events Am J Epidemiol 2002 156 634-40
Many general physicians now recommend influenza vaccination in patients with coronary artery disease CAD despite shortage of studies proving its protective effect on clinical course of CAD In literature we found only a few reports exploring the hypothesis that influenza vaccination might reduce the incidence of myocardial infarction MI and acute coronary syndromes ACS
Naghavi et all in retrospective case- control study of 218 patients with chronic coronary disease reported that influenza vaccination was strongly associated with freedom from new MI during the same influenza season OR 033 95 CI 013 to082 p0017 5 Gurfinkiel et all evaluated in prospective single- blind Fluvacs study that preventive impact of vaccination on subsequent ischemic events at 6 months follow-up Study group consisted of 301 patients after coronary angioplasty PCI The first primary outcome- cardiovascular death occurred in 2 in vaccine group compared with 8 in the control group p001 and triple composite end point death myocardial infarction and hospitalization from ischemia occurred in 11 in vaccine group vs 23 in controls p00009 6 In the contrary Jackson et all in largest study of 1378 survivors of first MI in long median 23 year follow-up didnt find the benefit of influenza vaccine on the protection against recurrent coronary events 7
The aim of our study is to evaluate the influence of influenza vaccination on the incidence of cardiac events cardiovascular death myocardial infarction acute coronary syndromes coronary revascularization and hospitalizations from ischemia in patients with angiographically confirmed coronary disease
References
1 Collins SD Excess mortality from causes other that influenza and pneumonia during influenza epidemics Public Health Rep 1932472159-80
2 Sorlie PD Adam E Melnick SL et al Cytomegalovirusherpesvirus and carotid atherosclerosis the ARIC Study J Med Virol 19944233-37
3 Zhou YF Wanishsawad C Epstein SE Chlamydia pneumonia-induced transaction of cytomegalovirus potential synergy of infectious agents in the pathogenesis of atherosclerosis J Am Coll Cardiol 199933suppl A260A
4 Toss H Lindahl B Siegbahn A Wallentin L Frisc study group Prognostic Influence of Increased Fibrinogen and C- reactive Protein Levels in Unstable Coronary Artery Disease Circulation 1997 96 4304- 4210
5 Naghavi M Barlas Z Siadaty S Nagiub S Madjid M Casscells W Association of influenza vaccination and reduced risk of myocardial infarction Circulation 2000 1023039-3045
6 Gurfinkel EP Leon de la Fuente R Mendiz O Mautner B For the FLUVACS Study Group Influenza vaccine pilot study in acute coronary syndromes and planned percutaneous coronary interventions The FLU vaccination acute coronary syndromes FLUVACS Study Circulation 20021052143-2147
7 Jackson LA Heckbert SR Psaty BM Malais D Barlow WE Thompson WW Vaccine Safety Datalink Study Group Influenza vaccination is not associated with a reduction in the risk of recurrent coronary events Am J Epidemiol 2002 156 634-40
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2 P05B 016 27 | None | None | None |