Home | All trials

[RDF data]
Trial NCT00607217

Resource URI: http://static.linkedct.org/resource/trials/NCT00607217
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/39986>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/39987>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/48972>
linkedct:brief_title The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases
linkedct:condition <http://static.linkedct.org/resource/condition/12414>
linkedct:condition <http://static.linkedct.org/resource/condition/3377>
linkedct:condition <http://static.linkedct.org/resource/condition/8483>
linkedct:criteria Inclusion Criteria: - Coronary artery disease (CAD) group (CAD-Exp and CAD-Control): - Patients with the diagnosis of acute, evolving or recent MI (after recovered the acute phase) as defined by: 1. Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following: - Ischemic symptoms - Development of pathologic Qwaves on the ECG - ECG changes indicative of ischemia (ST segment elevation or depression); OR - Coronary artery intervention (e.g., coronary angioplasty). 2. Pathologic findings of an acute MI [1]: - Patients with stable angina pectoris (SA) and documented coronary artery stenosis (angiography). - Healthy Control group: healthy controls, proportionally matched by gender and age with the patient group (separate control groups for MI and SA patients). Exclusion Criteria: - Any acute disease - Chronic liver or kidney diseases - Conditions accompanied by immunosuppression (like organ transplantation, HIV) - Diagnosed malignancy - Incubation with influenza vaccine within the past 5 years - Any psychological disease that interferes with regular follow-up - Congestive heart failure (Killip class IV) - Unstable angina; AND - Contradictions of vaccine incubation (like egg allergy).
linkedct:description Influenza infection may become complicated in patients with chronic conditions, including coronary artery disease (CAD) [1]. Influenza vaccination is now recommended as part of comprehensive secondary prevention in individuals with coronary and other atherosclerotic vascular disease (evidence level: Class I, Level B) [2]. Although there is controversial evidence pro [3,4] and against [5] the efficacy of influenza vaccination in protecting CAD population against cardiovascular events, the efficacy of vaccine in actual reduction in episodes of influenza infection and its fatal complications in CAD patients has not been, to our knowledge, well studied before. Furthermore, we found no report comparing serologic response to the influenza vaccine antigens between CAD patients and healthy controls. This study aims to identify the efficacy of influenza vaccination in CAD individuals in terms of both serologic response (as compared with healthy individuals) and clinical outcomes (as compared with CAD patients not vaccinated).
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers Accepts Healthy Volunteers
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 25 Years
linkedct:end_date September 2008
linkedct:enrollment 360 (xsd:int)
linkedct:firstreceived_date January 10, 2008
linkedct:has_dmc Yes
linkedct:id NCT00607217
linkedct:intervention <http://static.linkedct.org/resource/intervention/41223>
linkedct:intervention <http://static.linkedct.org/resource/intervention/41224>
rdfs:label Trial NCT00607217
linkedct:lastchanged_date January 20, 2009
linkedct:lead_sponsor_agency Shaheed Beheshti Medical University
linkedct:location <http://static.linkedct.org/resource/location/73005>
linkedct:nct_id NCT00607217
linkedct:number_of_arms 3 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Controlled Trial of Serologic and Clinical Efficacy of Influenza Vaccine in Post-Myocardial Infarction Patients and in Those With Stable Angina Pectoris
linkedct:org_study_id SBMU- 86-03-105-5433B
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/1559>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/23030>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/39288>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/42279>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/53737>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/53892>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/1388>
foaf:page <http://clinicaltrials.gov/show/NCT00607217>
linkedct:phase Phase 2/Phase 3
linkedct:primary_completion_date September 2008
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/27436>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/47152>
linkedct:reference <http://static.linkedct.org/resource/reference/13383>
linkedct:reference <http://static.linkedct.org/resource/reference/14800>
linkedct:reference <http://static.linkedct.org/resource/reference/19637>
linkedct:reference <http://static.linkedct.org/resource/reference/23740>
linkedct:reference <http://static.linkedct.org/resource/reference/30937>
linkedct:reference <http://static.linkedct.org/resource/reference/8101>
linkedct:secondary_id SMMC- 13861008B
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/58427>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/63287>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/90832>
linkedct:source Shaheed Beheshti Medical University
linkedct:start_date January 2008
linkedct:study_design Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary This study wishes to understand: 1. whether vaccination against influenza in coronary artery disease (myocardial infarction and stable angina) patients is as effective as it is in healthy subjects; 2. whether vaccination really decreases the episodes of influenza infection in those coronary artery disease patients who receive the vaccine than those who do not.
rdf:type linkedct:trials
linkedct:verification_date September 2008