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Sponsored by: |
Shaheed Beheshti Medical University |
Information provided by: | Shaheed Beheshti Medical University |
ClinicalTrials.gov Identifier: | NCT00607217 |
This study wishes to understand:
Condition | Intervention | Phase |
Coronary Artery Diseases Myocardial Infarction Stable Angina |
Biological: influenza vaccine Biological: placebo for influenza vaccine |
Phase II Phase III |
MedlinePlus related topics: | Angina Coronary Artery Disease Flu Heart Attack |
Drug Information available for: | Influenza Vaccines Fluvirin |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study |
Official Title: | Controlled Trial of Serologic and Clinical Efficacy of Influenza Vaccine in Post-Myocardial Infarction Patients and in Those With Stable Angina Pectoris |
Estimated Enrollment: | 360 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
CAD-Exp: Experimental
Enrolled coronary artery disease patients who are randomly assigned to receive influenza vaccine
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Biological: influenza vaccine
Intramuscular injection of one 0.5-mL dose of influenza vaccine
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CAD-Control: Placebo Comparator
Enrolled coronary artery disease patients who are randomly assigned to receive placebo of influenza vaccine
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Biological: placebo for influenza vaccine
Intramuscular injection of one 0.5-mL dose of placebo for influenza vaccine
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Healthy-Control: Experimental
Enrolled healthy subjects serve as control for CAD-Exp
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Biological: influenza vaccine
Intramuscular injection of one 0.5-mL dose of influenza vaccine
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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).
Ages Eligible for Study: | 25 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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:
Coronary artery intervention (e.g., coronary angioplasty).
2. Pathologic findings of an acute MI [1]:
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:
Iran, Islamic Republic of | |||||
Shaheed Modarres Medical Center | |||||
Tehran, Iran, Islamic Republic of |
Shaheed Beheshti Medical University |
Study Chair: | Maryam Keshtkar-Jahromi, M.D.; M.P.H. | Infectious Diseases and Tropical Medicine Research Center, Shaheed Beheshti Medical University, Tehran, Iran |
Principal Investigator: | Hossein Vakili, M.D. | Cardiovascular Research Center, Shaheed Beheshti Medical University, Tehran, Iran |
Principal Investigator: | Mohammad Rahnavardi, M.D. | Infectious Diseases and Tropical Medicine Research Center, Shaheed Beheshti Medical University, Tehran, Iran |
Principal Investigator: | Ali Eskandari, MD | Shaheed Beheshti University (MC) |
Principal Investigator: | Sharareh Gholamin, MD | Shaheed Beheshti University (MC) |
Principal Investigator: | Seyed Mostafa Razavi, MD | Shaheed Beheshti University (MC) |
Responsible Party: | Infectious Diseases and Tropical Medicine Research Center, SBMU, Tehran, Iran ( Maryam Keshtkar-Jahromi ) |
Study ID Numbers: | SBMU- 86-03-105-5433B, SMMC- 13861008B |
First Received: | January 10, 2008 |
Last Updated: | July 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00607217 |
Health Authority: | Iran: Ministry of Health |
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