APPENDIX-I
6. BRIEF RESUME OF THE INTENDED WORK
APPENDIX-1A
NEED FOR THE STUDY
Atrial fibrillation (AF) is characterized by irregular disorganized and
chaotic electrical activity of atria.
It is most common sustained cardiac rhythm disturbance, is increasing in
prevalence as population ages(7). Although it is often associated with heart disease, AF
occurs in many patients with no detectable disease. Hemodynamic impairment and
Thromboembolic events result in significant morbidity, mortality and cost.
The management and outcome depends on cause of AF.
APPENDIX-IB
6.2 REVIEW OF LITERATURE
Atrial fibrillation (AF) is defined as cardiac dysarrhythmia in which
effective contraction of atrial musculature is abolished with the bombardment of AV
node with very rapid irregular stimuli. Most of which being blocked at AVnode leading
to irregular ventricular rhythm. This can occur either in normal or in any diseased. It is of
more importance in diseased heart.
AF is grand father of cardiac arrhythmias known in 19th century as
arrhythmia perpetua, it was clearly defined clinically by Mackenzie and
electrocardiographically by Thomas Lewis at beginning of this century. (2)
Four important aspects of AF are(1)
1. Etiology
2. Control of ventricular rate
3. Prevention of recurrence
4. Prevention of thromboembolic episodes
PREVELENCE: AF is most common clinical significant cardiac arrhythmia. In one
series, AF accounted for 34.5% of patient of hospitalized with a cardiac rhythm
disturbance. (9)
Among the cross sectional studies of prevalence there is large gradient
across age categories, ranging from less than 0.5% in young adults to range of 1-5%
through the decades from 40-70 yrs and reaching rates in excess of 10% in some beyond
age 70yrs(3).Age adjusted prevalence is higher in men. (10)
TYPES OF AF:(3)
1. Paroxysmal: min/hours
-short lasting: seconds (< 1hr)
-long lasting: > 1hr < 48 hrs
2. Persistent: 2days-week
3. Chronic: months or years
ETIOLOGY: Persistent AF occurs in patient with cardiovascular disease most
commonly rheumatic heart disease, non rheumatic mitral valve disease, hypertensive
cardiovascular disease, chronic lung disease, ASD and a variety of miscellaneous cardiac
abnormalities. AF may be presenting finding in thyrotoxicosis. Lone AF occurs in
patients without under laying heart disease. (11)
In the Indian subcontinent, RHD still accounts for significant number of hospital
admissions and one-fourth of patients with rheumatic valvular heart disease have
AF.(10)
CLINICAL FEATURES: clinical presentation ranges from minimal symptomatic or
asymptomatic incidental finding to acute pulmonary edema in patient with advanced
mitral or aortic stenosis. Between these extremities AF may herald the presence of non-
cardiac disorder, alert to significant of another cardiac disorder, constitute a transient
factor of another cardiac disorder or occur as an isolated event having no inherent
significance.(11)
COMPLICATIONS: Morbidity associated with AF is related to (11)
1. excessive ventricular rate
2. systemic embolization
3. the pause following cessation of AF
MANAGEMENT: Major issues in management of patient with AF are related to
arrhythmia itself and to prevention of thromboembolism. In patients with persistent AF,
there are fundamentally two ways to manage dysrhythmia; to restore and maintain sinus
rhythm or to allow AF to continue and ensure that ventricular rate is controlled.
RATE CONTROL: In elderly patient, valvular heart disease patients awaiting
intervention and those with left atrium larger than 6 cm should be managed with rate
control strategy. (4)
RHYTHM CONTROL: In young patients and those with rheumatic valvular heart
disease but not significant valve compromise, restoring and maintaining sinus rhythm
should be attempted.
ANTI COAGULATION: Need for anticoagulation in AF is based on presence of risk
factors for thromboembolism. Risk factors include rheumatic valvular heart disease,
age>65 years, severe left ventricular hypertrophy, congestive heart failure, diabetes and
prior transient ischemic attack or stroke [5,6]
APPENDIX-IC
6.3 AIM AND OBJECTIVES
Aim of the study is to analyze atrial fibrillation
1. with regard to its frequency
2. age, sex distribution
3. various etiological factors
4. complications
5. various available ways of management including anticoagulant therapy
APPENDIX-1D
6.4 SELECTION OF SUBJECTS
Patients with definitive evidence of atrial fibrillation on clinical
examination and 12 lead ECG will be included in this study.
APPENDIX-II
7. 0 MATERIALS AND METHODS
APPENDIX-IIA
7.1 SOURCE OF DATA
Study will be carried out in sri Adichunchanagiri institute of medical
science and research center B.G.Nagar from nov 2007 to april 2009.
APPENDIX-IIB
7.2 METHOD OF COLLECTION OF DATA
This study will be based on analysis of 50 consecutive patients of AF in
reference to incidence, etiological factors, complications , ECG finding ,treatment
and other investigation like chest radiography and echocardiography. The findings of the
examination and results of all investigations will be recorded and tabulated.
APPENDIX-IIC
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER ANIMALS, IF SO PLEASE DISCRIBE BRIEFLY.
YES
INVESTIGATIONS
BLOOD:
1. Hb%, TC, DC, ESR
2. FBS/PPBS/RBS
3. BLOOD UREA SERUM CREATININE
4. SERUM LIPID PROFILE
5.SREUM ELECTROLYTES
URINE ROUTINE
ECG
CHEST X-RAY
ECHOCARDIOGRAPHY
APPENDIX-III
8.O LIST OF REFERENCES
1.Jeffery E .olgin/ Douglas P . Zipes ; Specific arrhythmias: Diagnosis & Treatment :
Brawnwald`s heart disease : 7th edition : 816-817
2. Kenneth M. Flegel, 1995 ; from delirium cordis to atril fibrillation; historical
development of disease concept; ann internal med, 122: 867-873.
3.Robert J myerburg/ Kenneth M Kessles / Agustin castellana : Recognition , clinical
Assessment & Management of arrhythmias & conduction disturbances: Hurt`s The Heart
:volume one :9th edition ;896-897
4. . Vora A, Karnad D, Goyal V, Naik A, Lokhandwala Y, KulkarniH, Singh B. Control of rate
versus rhythm in rheumatic atrialfibrillation: a randomized study. Indian Heart J 2004;56:110-16.
5.. Kannel WB, Abbott RD, Savage DD, McNamara PM.Epidemiologic features of chronic atrial
fibrillation: theFramingham study. N Engl J Med 1982;306:1018-22.
32 © SUPPLEMENT OF JAPI • APRIL 2007 • VOL. 55
6.. Alpert JS, Peterson P, Godtfredsen J. Atrial fibrillation: natural history, complications and
management. Annu Rev Med 1988;39:41-52.
7..A.D. Krahn, J. Manfreda, R.B. Tate, F.A.L. Mathewson and E.T. Cuddy, The natural history of atrial fibrillation: incidence, risk factors, and prognosis in the Mannitoba Follow-up study, Am J Med98 (1995), pp. 466–484.
8..Diker E, Aydogdu S, Ozdemir M, Kural T, Polat K, Cehreli S, et al. Prevalence
and predictors of atrial fibrillation in rheumatic valvular heart disease. Am J Cardiol
1996; 77: 96–98
9..Bialy D, Lehmann MH, Schumacher DN, Steinman RT, Meissner MD.
Hospitalization for Arrhythmias in the United States: Importance of Atrial
Fibrillation[abstr]. J Am Coll Cardiol. . 1992; 19: 41A.
10.Furberg CD, Psaty BM, Manolio TA, Gardin JM, Smith VE, Rautaharju PM.
Prevalence of atrial fibrillation in elderly subjects (the Cardiovascular Health Study). Am
J Cardiol. . 1994; 74: 236–41.
11..Mark E josephson/Peter zimetbaum ; The Tachyarrythmias ; Harrison`s Principles of
Internal Medicine; 16th edition ; volume 2;1345
APPENDIX-IID
PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL
SECTION AA. / Title of the study / “A CLINICAL AND ELECTROCARDIOGRAPHIC STUDY OF ATRIAL FIBRILLATION”
B. / Principal investigator / DR. VIJAY KUMAR T.R
P.G (M.D)IN GENERAL MEDICINE
C. / Co-investigator
GUIDE / DR.PADMANABHA M.C
PROFESSOR & HOD
DEPT. MEDICINE
A.I.M.S., B.G.NAGAR
D. / Name of the collaborator
Department / institute / NA
E. / Whether permission has been obtained
from the head of the collaborating
department and institution / NA
SECTION-B
Summary of the project / APPENDIX-II
SECTION-C
Objective of the study / APPENDIX-IC
SECTION –D
Methodology / APPENDIX-IIB
A. / Where the proposed study will be
Undertaken / AH & RC, B.G.NAGARA.
B. / Duration of the project / 18 MONTHS
C. / Nature of the subject :
Does the study involve adult patients?
Does the study involve children?
Does the study involve normal volunteers? / YES
YES
NO
Does the study involves psychiatric
patients?
Does the study involve pregnant women? / NO
YES
D. / If the study involves healthy volunteers
1. will they be institute students?
2. will they be institute employees?
3. will they be paid?
4. if they are to be paid, how much per person? / NO
NO
NA
NA
E. / Is the study multi central trial? / NO
F. / If yes, who is the coordinator?
(name and designation)
Has the trial been approved by the ethical committee of other centers?
If the study involves the usage of drugs:
Please indicate whether,
1. the drug is marketed in India for the indication in which it will be used in the study.
2. the drug is marketed in India but not
for the indication in which it will be used in the study.
3. the drug is only used for experimental use in humans.
4.clearance of the drug controller of India has been obtained for :
-Use of the drug in the healthy volunteers
-Use of drug in-patients for a new indication. / NA
NA
NA
NA
NA
NA
NA
-phase one and two clinical trials.
-experimental use in-patients and healthy volunteers. / NA
NA
G. / How do you propose to obtain the drug to be used in the study?
-Gift from a drug company
-hospital supplies
-patients will be asked to purchase
-other sources (Explain) / NA
NA
NA
NA
NA
H. / Funding (if any) for the project.
Please state.
-None
-Amount
-Source
-To whom payable / NONE
I. / Does any agency have a vested interest in
the outcome of the project? / NO
J. / Will data relating to subjects/controls be
stored in a computer? / NO
K. / Will the data analysis be done by
-The researcher?
-The funding agency / YES
NO
L. / Will technical / nursing help be required
for the staff of hospital, if yes,
will it interfere with their duties ?
will you recruit other staff for the duration of the study?
If yes give details of
I Designation
II Qualification
III Number
IV Duration of employment / NO
NO
NA
NA
NA
NA
M. / Will informed consent be taken?
If yes,
Will it be written informed consent?
Will it be oral consent?
Will it be taken from the subjects themselves?
Will it be from the legal guardian?
If no, give reason: / YES
YES
NO
YES
NA
N. / Describe design, Methodology and
Techniques / APPENDIX-II
Ethical clearance has been accorded.
Date:
Place:
Chairman
PG Training-cum research committee
A.I.M.S., B.G.Nagar