Status:
COMPLETED
The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases
Lead Sponsor:
Shahid Beheshti University of Medical Sciences
Conditions:
Coronary Artery Diseases
Myocardial Infarction
Eligibility:
All Genders
25+ years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed 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 seconda...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00607217
Start Date
January 1 2008
End Date
September 1 2008
Last Update
January 22 2009
Active Locations (1)
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1
Shaheed Modarres Medical Center
Tehran, Tehran Province, Iran