RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
SYNOPSIS OF DISSERTATION
“A CLINICAL STUDY OF ARRYTHMIAS DURING THE FIRST 48 HOURS OF ACUTE MYOCARDIAL INFARCTION”
Submitted by
Dr. MUTHU RAJU. N. MBBS
POST GRADUATE STUDENT IN
GENERAL MEDICINE (M.D.)
Under the guidance of
Dr. SHETTY SHIVAKUMAR. M. MBBS. M.D
PROFESSOR
DEPARTMENT OF GENERAL MEDICINE,
A.I.M.S., B.G.NAGARA-571448
DEPARTMENT OF GENERAL MEDICINE
ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES,
B.G.NAGARA-571448
2013
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / NAME OF THE CANDIDATEAND ADDRESS
(in block letters) / Dr. MUTHU RAJU. N.
POST GRADUATE STUDENT IN GENERAL MEDICINE (M.D)
ADICHUNCHANAGIRI INSTITUTE OF
MEDICAL SCIENCES, B.G.NAGARA.
2. / NAME OF THE INSTITUTION /
ADICHUNCHANAGIRI INSTITUTE OF
MEDICAL SCIENCES, B.G.NAGARA.3. / COURSE OF STUDY AND SUBJECT /
M.D. IN GENERAL MEDICINE
4. / DATE OF ADMISSION TO COURSE / 29/07/20135. / TITLE OF THE TOPIC / “A CLINICAL STUDY OF ARRYTHMIAS DURING THE FIRST 48 HOURS OF ACUTE MYOCARDIAL INFARCTION”
6. / BRIEF RESUME OF INTENDED WORK
6.1 NEED FOR THE STUDY
6.2 REVIEW OF LITERATURE
6.3 OBJECTIVES OF THE STUDY / APPENDIX-I
APPENDIX-IA
APPENDIX-IB
APPENDIX-IC
7 / MATERIALS AND METHODS7.1 SOURCE OF DATA
7.2 METHOD OF COLLECTION OF DATA : (INCLUDING SAMPLING PROCEDURE IF ANY)
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER ANIMALS, IF SO PLEASE DESCRIBE BRIEFLY.
7.4 HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3 / APPENDIX-II
APPENDIX-IIA
APPENDIX-IIB
YES
APPENDIX-IIC
YES
APPENDIX-IID8. / LIST OF REFERENCES /
APPENDIX – III
9. / SIGNATURE OF THE CANDIDATE /10. /
REMARKS OF THE GUIDE
/ Recommended11 / NAME AND DESIGNATION
(in Block Letters)
11.1 GUIDE / Dr. SHETTY SHIVAKUMAR. M. MBBS, MD
PROFESSOR,
DEPARTMENT OF GENERAL MEDICINE,
A.I.M.S, B.G.NAGARA.
11.2 SIGNATURE OF THE GUIDE
11.3 CO-GUIDE (IF ANY) / -
11.4 SIGNATURE / -
11.5 HEAD OF DEPARTMENT / Dr. H. VASUDEVA NAIK, MBBS, MD
PROFESSOR AND HEAD,
DEPARTMENT OF GENERAL MEDICINE,
A.I.M.S, B.G.NAGARA.
11.6 SIGNATURE
12 / 12.1 REMARKS OF THE CHAIRMAN
AND PRINCIPAL / The facilities required for the investigation will be made available by the college
Dr. M.G SHIVARAMU MBBS, MD
PRINCIPAL,
AIMS, B.G. NAGARA.
12.2 SIGNATURE
APPENDIX-I
6. BRIEF RESUME OF THE INTENDED WORK:
APPENDIX –I A
6.1 NEED FOR STUDY:
The profile of coronary artery disease is different in India in terms of incidence and risk factors. Indians show higher incidence of hospitalization, morbidity and mortality than other ethnic groups. Also, South Indian have higher prevalence. Majority of deaths in acute myocardial infarction are due to arrhythmias1.
This study is undertaken to study the profile of arrhythmias in acute myocardial infarction during the first 48 hours of hospitalization in our hospital. A substantial number of patients with acute myocardial infarction have some cardiac rhythm abnormality, and approximately twenty-five percent have cardiac conduction disturbance within 48 hours following infarct onset. Almost any rhythm disturbance can be associated with acute myocardial infarction, including bradyarrhythmias, supraventricular tachyarrhythmias, ventricular arrhythmias, and atrio ventricular block. With the advent of thrombolytic therapy, it was found that some rhythm disturbances in patients with acute myocardial infarction may be elated to coronary artery reperfusion2.
The purpose of this study is to evaluate the incidence and profile of cardiac arrhythmias in acute myocardial infarction in the first 48 hours of hospitalization. Attention is given to the peri infarction period (arbitrarily accepted as within 48 hours of myocardial infarction) as arrhythmias are most likely to be seen around this time3.
APPENDIX –I B
6.2 REVIEW OF LITERATURE
HISTORICAL ASPECTS
It is perhaps impossible to identify the very first person who observed variations in the cardiac rhythm. However, the review of history of medicine, in this regard is helpful in identifying at least some milestones in our understanding of this clinical problem. Among the ancient times, it is said that Egyptians were aware of the importance of the examination of pulse as early as 13th Century before Christ. Chinese considered it as a key to diagnose many condition in 6th century B.C. Just around this time, it is said that 600 types of pulses were known to Ayurvedic physicians. In the year 1628 A.D, Sir William Harvey described circulation of blood. In the year 1776, William Withering recognized the irregular pulse of atrial fibrillation. In 1835, Boulland recognised two important abnormalities in the pulse, which he called pulse intermittens and ataxia of the pulse (possibly atrial fibrillation). Nothangel likened the irregularity of the heart rhythm in ataxia of the pulse to the delirious state of the brain and hence called it ‘celirium cordis’.
Deaths most commonly occur within one hour of acute myocardial infarctions. Early deaths are not related to the severity of infarct but observations from monitoring units suggest that the mechanism in most of the cases is arrhythmias and cardiac asystole. Other findings that augur poorly are repetitive ventricular ectopic activity, persistent horizontal or down sloping ST segment depression, Q waves in multiple leads, atrial fibrillation, and voltage criteria for left ventricular hypertrophy, an abnormal signal averaged ECG, left ventricular dysfunction.6,8-11
The ICCUs have provided a wealth of new knowledge on the natural history, incidence of arrhythmias and the prognosis of AMI in hospitalized patients.13.
Managing arryhythmias as per ACLS protocol care prevention, complication and sudden death in hospital settings.12
The risk of CAD in Indians is 3-4 times higher than White Americans and 6 times higher than Chinese. The prevalence of coronary artery disease in Asian Indians4 has to be viewed with concern. Indians are prone as a community to CAD at a much younger age.5
In the study by SZ Abildstrom et al14 as compared to non- sudden cardiac death, the risk of sudden cardiac death, is relatively highest in the younger age groups, but the absolute risk of sudden cardiac death, is much higher among the upper age groups than the younger.
In the Framingham Heart study a male preponderance as was observed.15
In a prospective community based study by Shmuel Gottlieb et al16 of consecutive AMI patients hospitalised in ICCUs in the mid 1990s indicate that women fare significantly worse than men at 30 days.
In a study by Wolfe CL et al,17 polymorphic VT seen in 2% of patients with MI is often rapid, symptomatic and hemodynamically and electrically unstable.
In a study by Tofler GH et al,18 sustained VT occurring within 48 hours of MI seen in 2% of patients is often transient and is not associated with long –term risk of sudden cardiac death.
A substantial number of patients with acute myocardial infarction have some cardiac rhythm abnormality, and approximately twenty-five percent have cardiac conduction disturbance within 48 hours following infarct onset. Almost any rhythm disturbance can be associated with acute myocardial infarction, including bradyarrhythmias, supraventricular tachyarrhythmias, ventricular arrhythmias, ventricular tachycardia and atrio ventricular block. With the advent of thrombolytic therapy, it was found that some rhythm disturbances in patients with acute myocardial infarction may be elated to coronary artery reperfusion.2
Thygesen et al12 ESC/ACCF/AHA/WHF Third Universal Definition of MI “Detection of rise and /or fall of cardiac biomarker values [preferably cardiac troponin (cTn)] with at least one value above the 99th upper reference limit (URL)” and with atleast one of the following:
· Symptoms of ischaemia.
· New or presumed new significant ST-segment –T wave (ST-T) changes or new left bundle branch block (LBB).
· Development of pathological Q waves in the ECG.
· Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
· Identification of an antracoronary thrombus by angiography or autopsy.
Coronary artery bypass grafting (CABG) related MI is arbitrarily defined by elevation of cardiac biomarker values (>10×99th percentile URL) in patients with normal baseline cTn values (≤ 99th percentile URL). In addition either (i) new pathological Q waves or new LBB, or (ii) angiographic documented new graft or new native coronary artey occlusion, or (iii) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
APPENDIX –I C
6.3 AIMS AND OBJECTIVES OF STUDY
1. The aim of the present study is to study the pattern of arrhythmias during first 48 hours of acute myocardial infarction.
2. To study clinical profile and risk factors, complications and hospital outcome of Acute myocardial infarction patients among patients.
APPENDIX-II
7.0 MATERIALS AND METHODS
APPENDIX-II A
7.1 SOURCE OF DATA
The data will be obtained from total of 100 patients admitted to the ICCU, Sri Adichunchanagiri Hospital and Research Centre, B.G. Nagara. The study conducted is prospective study.
Study Period : 18 months
Type of Study : Prospective study
APPENDIX-II B
7.2 METHOD OF COLLECTION OF DATA
INCLUSION CRITERIA
1. Patients 18 years of age or above admitted in the ICCU with acute myocardial infarction.
2. Myocardial infarction less than 48 hours old.
EXCLUSION CRITERIA
1. Patients less than 18 years of age
2. Myocardial infarction 48 hours old or more
Statistical Methods :
The data obtained will be analyzed by Prospective statistics by means of percentage, proportions, age and depicted via bar charts, pie charts, Chi square.
APPENDIX-II C
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so describe briefly?
YES
INVESTIGATIONS :
o Blood routine
o Random blood sugar
o ECG
o CPK MB
o TROPONIN T
o Blood urea, serum creatinine
o Serum electrolytes
o Serum calcium, magnesium
o 2-D Echocardiography.
APPENDIX-IID
PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL
SECTION A
a / Title of the study / “A CLINICAL STUDY OF ARRYTHMIAS DURING THE FIRST 48 HOURS OF ACUTE MYOCARDIAL INFARCTION”b / Principle investigator
(Name and Designation) / Dr. MUTHU RAJU. N.
POST GRADUATE STUDENT IN GENERAL MEDICINE (M.D)
ADICHUNCHANAGIRI INSTITUTE OF
MEDICAL SCIENCES, B.G.NAGARA.
c / Co-investigator
(Name and Designation) / Dr SHETTY SHIVAKUMAR. M. M.B.B.S, M.D
PROFESSOR,
DEPARTMENT OF GENERAL MEDICINE,
A.I.M.S, B.G.NAGARA.
d / Name of the Collaborating
Department/Institutions / NO
e / Whether permission has been obtained from the heads of the collaborating departments & Institution / NA
Section – B
Summary of the Project /
APPENDIX – I
Section – C
Objectives of the study /APPENDIX – IC
Section – D
Methodology /APPENDIX – IIB
A / Where the proposed study will be undertaken / ADICHUNCHANAGIRI HOSPITAL AND RESEARCH CENTRE, B.G.NAGARAB / Duration of the Project /
18 MONTHS
C / Nature of the subjects:Does the study involve adult patients?
Does the study involve Children?
Does the study involve normal volunteers?
Does the study involve Psychiatric patients?
Does the study involve pregnant women? / YES
NO
NO
NO
NO
D / If the study involves health volunteers
I. Will they be institute students?
II. Will they be institute employees?
III. Will they be Paid?
- If they are to be paid, how much per session?
NO
NO
NO
E / Is the study a part of multi central trial? / NO
F / If yes, who is the coordinator?
(Name and Designation)
Has the trail been approved by the ethics Committee of the other centers?
If the study involves the use of drugs please indicate whether.
I. The drug is marketed in India for the indication in which it will be used in the study.
II. The drug is marketed in India but not for the indication in which it will be used in the study
III. The drug is only used for experimental use in humans.
IV. Clearance of the drugs controller of India has been obtained for:
Use of the drug in healthy volunteers
Use of the drug in-patients for a new indication.
Phase one and two clinical trials
Experimental use in-patients and healthy volunteers. / NA
NA
-
NA
NA
NA
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
H / Funding (If any) for the project please state
- None
- Amount
- Source
- To whom payable / NO
I / Does any agency have a vested interest in the out come 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 agent / YES
NO
L / Will technical / nursing help be required form 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
- Duration of Employment
NO
NO
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 subject themselves?
Will it be from the legal guardian? If no, give reason: / NO
NA
NA
NA
NA
N / Describe design, Methodology and techniques / APPENDIX II
Ethical clearance has been accorded.
Chairman,
P.G Training Cum-Research Institute,
A.I.M.S., B.G.Nagara.
Date :
PS : NA – Not Applicable
APPENDIX-III
8. LIST OF REFERENCES
1. Enas EA, Dhawan J, Petkar S. Coronary artery diseases in Asian Indians: Lessons learnt and the role of lipoprotein -a. Indian Heart J. 1996; 49: 25-34.
2. Aufderheide TP. Arrhythmias associated with acute myocardial infarct ion and thrombolysis. Emerg Med Clin North Am. 1998 Aug; 16(3): 583-600.
3. A V Ghuran and A J Camm. Ischaemic heart disease presenting as arrhythmias. BMB 2001; 59: 193-210.
4. Enas EA, Yusuf S, Mehta JL. Prevalence of coronary artery disease in Asian Indians. Am J Cardiol 2001; 88 (2): 201-2.
5. Janus ED, Postiglione A, Singh RB, Barry Lewis. The modernization of Asia: Implications for coronary heart disease. Circulation 1996; 94: 2671-2673.
6. AR Denniss, DA Richards, DV Cody, PA Russell, AA Young, MJ Cooper et al. Prognostic significance of ventricular tachycardia and fibrillation induced at programmed stimulation and delayed potentials detected on the signal averaged electrocardiograms of survivors of acute myocardial infarct ion. Circulation 1986; 74: 731.