RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION
TOPIC
“STUDY OF ARRYTHMIAS WITHIN 48 HOURS OF ACUTE
MYOCARDIAL INFARCTION”
Dr. ATIF AHMED.S
POST GRADUATE STUDENT
DEPARTMENT OF GENERAL MEDICINE
KVG MEDICAL COLLEGE AND HOSPITAL,
SULLIA-574327
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / NAME OF THE CANDIDATE AND ADDRESS / DR. ATIF AHMED.SPG IN GENERAL MEDICINE,
K.V.G MEDICAL COLLEGE HOSPITAL
KURUNJIBAG, SULLIA ,D.K-574327
2. / NAME OF THE INSTITUTION / K.V.G MEDICAL COLLEGE HOSPITAL
KURUNJIBAG, SULLIA ,D.K-574327
3. / COURSE OF STUDY AND SUBJECT / M.D. IN GENERAL MEDICINE.
4. / DATE OF ADMISSION TO COURSE / 28-05-2013
5. / TITLE OF TOPIC / “STUDY OF ARRHYTHMIAS WITHIN 48HOURS OF ACUTE MYOCARDIAL INFARCTION”
6 / BRIEF RESUME OF THE INTENDED WORK.
6.1 Need for the study
Cardiovascular disease is the commonest cause of death globally and account for approximately 12 million deaths annually. Coronary Artery disease (CAD) among Asian Indians have been found to be more severe, diffuse, and associated with severe complications and increasing mortality at an young age.Developing countries account for 80% of the burden.1
Despite impressive strides in diagnosis and management over the last three decades, acute myocardial infarction(AMI) continues to be major public health problem in the industrialized world. Although the death rate of AMI has declined by about 30% over last decade, its development is still a fatal event in approximately one third of the patients.2
Many of these deaths are attributed to the development of Arrhythmias during periods of Myocardial Infarction.
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 Brad arrhythmias, Supra VentricularTachyarrhythmias , Ventricular Arrhythmias, and Atrioventricular block.
Cardiac Arrhythmias & particularly Ventricular Tachyarrhythmias is a common complication of acute myocardial infarction (AMI). It is estimated that serious Ventricular Tachy-arrhythmias are responsible for death in 50% of patients of cardiovascular disease (CVD) patients.1No data are available from India to date on the prevalence of post- MI arrhythmias, its treatments and outcomes.
The purpose of this study is to evaluate the incidence and profile of cardiac Arrhythmias in Acute Myocardial Infarction. Attention is given to the peri-infarction period (within 48 hours of myocardial infarction) as Arrhythmias are most likely to be seen around this time.
6.2 REVIEW OF THE LITERATURE
1. Patricia Jabre et al in their study concluded that of 3220 patients hospitalized with incident MI from 1983 to 2007 in Olmsted country. Atrial fibrillation was identified by diagnostic codes and ECG. Outcomes were all cause of cardiovascular death. AF before MI was identified in 304 patients, and 729 developed AF after MI (218 within 2 days, 119 between 3 and 30 days, and 392 more than 30 days post MI). AF was associated with an increased risk of death, independently of clinical characteristics at the MI and heart failure; the risk differed markedly according to the timing of AF, and was greatest for AF occurring more than 30 days post MI.3
2. Martin St.John Sutton et al in their study conducted on 263 subjects in which Transthoracic 2D Echocardiogram and arrhythmia monitoring were performed at baseline , 1 year and 2 years of infarction,. The prevalence of Ventricular tachycardia(VT) and frequent Ventricular ectopics were assessed from ECG.The study showed the prevalence of VT and PVC’s in 20% and 29% at baseline, 22% and 35% at 1 year, 33% and 39% at 2 years respectively.The conclusion was that altered LV architecture and function during post infarction LV remodeling provide an important substrate for triggering high grade Ventricular Arrhythmias.4
3. Jane S.Saczynski et al in their study concluded that of 7513 residents of the Worcester, Massachusetts,metropolitan area, overall incidence of AF complicating AMI was 13.3%. Post discharge survival was significantly poorer in patients who developed AF. In conclusion AF remains a frequent complication of AMI and is associated with poor prognosis.5
4. Keith.H.Newby et all in their study conducted on 40,895 patients with Ventricular Arrhythmia data found 4,188(10.2%) had sustained Ventricular Tachycardia , Ventricular fibrillation or both and the conclusion was that both early and late occurrence of sustained Ventricular Tachycardia or Ventricular Fibrillation continue to have a negative impact on patient outcome. Patient with both Ventricular Tachycardia and Ventricular have worst prognosis.6
5. Tom P Aufderheide, conducted a study where ninety percent of patients with acute MI have some cardiac rhythm abnormality & 25% have a cardiac conduction Disturbance within 24 hrs of infarct onset. The incidence ( 4.5%) of serious arrhythmias such as ventricular fibrillation is a greatest in the first hour of an acute MI. Almost all AMI patients initially exhibit increased Autonomic Nervous System activity , resulting in Sinus Bradycardias , sometimes , associated with atrioventricular block.7
6. Jonathan P.Piccini et all in their study concluded thatof the 9015 patients who underwent percutaneous coronary intervention for AcuteMI, 472 (5.2%) developed sustained ventricular tachycardia or fibrillation before revascularization after multi variable adjustment , independent predictors ofsustained VT/VF included cardiogenic shock . patients with sustained VT/VF had greater in hospital mortality, patients with VT/VF and successful revascularization experienced increased mortality compared with patients without sustained ventricular arrhythmias.8
6.3 AIMS AND OBJECTIVES OF THE STUDY:To study the pattern of Arrhythmias over 48 hours following acute myocardial infarction .
7. / MATERIALS AND METHODS :
· A minimum of 100 patients admitted in MICU, with diagnosis of Acute MI will be taken for the study considering the inclusion and exclusion criteria.
· Patient will be put on Cardiac Monitor and followed for 48 hours and pattern of Arrhythmias will be noted during the stay in MICU.
7.1 SOURCE OF DATA:
A minimum of 100 patients admitted in MICU, Department of Medicine ,
K.V.G. Medical college and Hospital, Sullia,during the study period of 18 months (1stDecember 2013 – 31st May 2015)willbe taken considering the inclusion and exclusioncriteria.
METHODS OF COLLECTION OF DATA:
· Information will be collected through a pre tested and structured proforma for each patient.
· The study will be carried out on patients presenting with clinical features & ECG findings suggestive of ACUTE MYOCARDIAL INFARCTION.
· In all the selected patients detailed history and physical examination will be noted. Every patient will be subjected to12 lead ECG with serial monitoring.
· Every patient will be put on Cardiac Monitor for 48 hours following admission in MICU and will be monitored serially.
·
SAMPLE SIZE: A total of 100 patients after considering the inclusion and exclusion criteria will be taken up for study.
TYPE OF STUDY:Prospective study.
SAMPLING:Sampling was calculated considering 75% of average number of admissions of Acute Myocardial Infarction cases in MICU over the last 3 years.
However this being a time bound study(18 months study) all the patients admitted with acute myocardial infarction in KVGMCH MICU during this period will be taken up for study.
Inclusion criteria :
1. More than 18 years of age
2. Patients with documented MI based on two of the following three criteria:
A .Patients in whom a clinical diagnosis of MI was made based upon typical signsand symptoms; previous history of ischemic heart disease.
B. ECG findings suggesting STEMI(ST segment elevation myocardial infarction) or NSTEMI (Non- ST segment myocardial infarction).
C .Elevated cardiac markers (Creatinine phosphokinase, troponin-T).
Exclusion criteria:
1. Patients < 18years of age
2. Patients with Congenital Heart Disease
3. Patients with valvular Heart disease
4. Patients with electrolyte imbalance
5. Patients treated elsewhere and referred to this hospital for further management
Statistical Analysis: Data will be analyzed by appropriate statistical methods.
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? (If so, please describe briefly)
yes,
1. Routine blood investigations
2. 12 – lead ECG
3. 2D ECHO
4. Serum Electrolytes
5. Cardiac Markers
6. Cardiac Monitoring.
7.4 Has ethical clearance been obtained from ethical committee of your institution in case of 7.3?
Institutional ethics committee clearance copy enclosed.
8 / References:
1. Naik N, Yadav R, Juneja R. Epidemiology of arrhythmias in India: how do we obtain reliable data? Current Science2009; 97(3): 411-15.
2. Sigurdsson E, Thorgeirsson G, Sigvaldason H & Sigfusson N. Unrecognised myocardial infarction Epidemiology, clinical characteristic and the prognostic role of angina pectoris (The Reykjavik study). Ann intern Med.1995; 122:96-102
3. Jabre P et al: atrial fibrillation and death after myocardial infarction. A community Study. Circulation. 2011;123:2094-100.
4. Sutton MSJ, Lee D, Rouleau JL,Left Ventricular Remodeling and Ventricular Arrhythmias after Myocardial Infarction, .American Heart Association Journals, 2003,2577-82.
5. Saczynski J et al: trends in atrial fibrillation complicating acute Myocardial Infarction. Am J Cardiol 2009;104:169-174.
6. Newby KH, Thompson T, Stebbins A, Topol E, Califf RM ,Natale A.Sustained Ventricular Arrhythmias in Patients ReceivingThrombolytic Therapy;Journal of The American Heart Association,Circulation.; 1998;98:2567-73.
7. Aufderheide TP,Aarrhythmias associated with acute myocardial infarction and thrombolysis. Emergengy medicine clinics of North America – volume 16, Issue 3;1998.
8. Piccini JP, Berger SJ, Brown DL, Early sustained ventricular arrhythmias complicating acute Myocardial Infarction. The American journal of medicine (2008) 121, 797-804.
9. / SIGNATURE OF THE CANDIDATE
10. / REMARKS OF THE GUIDE / RECOMMENDED AND FORWARDED
11. / NAME AND DESIGNATION OF
11.1 GUIDE / Dr. S. VISHWESHWARAN
Professor, Department of General Medicine, K.V.G. Medical college, Sullia, D.K
11.2 SIGNATURE
11.5 HEAD OF THE DEPARTMENT / Dr GOPAL RAO S
Professor and HOD,
Department of General Medicine
K.V.G Medical College, Sullia, D.K.
11.6 SIGNATURE
12 / 12.1 REMARKS OF THE PRINCIPAL
12.2 SIGNATURE
INSTITUTIONAL ETHICAL COMMITTEE CLEARANCE
1. / TITLE OF DISSERTATION: / “STUDY OF ARRHYTHMIAS WITHIN 48 HOURS OF ACUTE MYOCARDIAL INFARCTION”2. / NAME OF THE CANDIDATE: / Dr. ATIF AHMED.S
3. / NAME OF THE GUIDE: / Dr. S.VISHWESHWARAN
4. / APPROVED/NOT APPROVED
5 / LAW EXPERT / Mr. KRISHNAMURTHY, Advocate.
PRINCIPAL
K.V.G MEDICAL COLLEGE AND HOSPITAL, SULLIA.
Name : Address :
Age : Gender :
Occupation : D.O.A :
Education : D.O.D :
Marital status : I.P NO :
Unit : Ward : MICU
PRESENTING COMPLAINTS
Ø Chest pain
Ø Sweating
Ø Dyspnoea
Ø Anxiety
Ø Sudden loss of consciousness
PAST HISTORY
Angina, Ischemic Heart Disease, Hypertension, Diabetes.
FAMILY HISTORY
DRUG HISTORY
PERSONAL HISTORY
Diet : Appetite :
Sleep : Bladder:
Bowel habits:
Habits :
Smoking : Alcohol: Tobacco chewing:
GENERAL PHYSICAL EXAMINATION
GENERAL
Pallor/Icterus/Clubbing/Cyanosis/Lymphadenopathy//Edema
VITAL SIGNS
Pulse: Blood Pressure:
Respiratory Rate: Temperature:
SYSTEMIC EXAMINATION
CARDIOVASCULAR SYSTEM EXAMINATION
INSPECTION
Precordial bulge/Apical impulse/other pulsations
PALPATION
Apex/Leftparasternal heave/ Epigastric pulsations/Supraclavicular pulsations/Thrills/other pulsations
PERCUSSION : BORDERS
AUSCULTATION
Heart sounds, splits,added sounds,loudness etc.
Murmurs
Pericardial rub
RESPIRATORY SYSTEM
PER ABDOMINAL EXAMINATION
CENTRAL NERVOUS SYSTEM EXAMINATION
INVESTIGATIONS
1.12 –LEAD ECG.
2.CARDIAC MARKERS.
A.CREATINE PHOSPHOKINASE-MB
B.TROPONIN
3.2D ECHOCARDIOGRAPHY
4.SERUM ELECTROLYTES
A.SODIUM
B.POTTASIUM
C.CHLORIDE
5.ROUTINE BLOOD INVESTIGATIONS
A.HAEMOGLOBIN
B.TOTAL COUNT
C.DIFFERENTIAL COUNT
D.ESR
E.PLATELET COUNT
F.UREA/CREATININE
6.OTHER INVESTIGATIONS.
INFORMED CONSENT FOR PARTICIPATION IN RESEARCH
I Dr. ATIF AHMED.S, Post graduate in Department of General Medicine, I am conducting a Research work for award of M.D. degree in General Medicine.
The topic of study:
“STUDY OF ARRYTHMIAS WITHIN 48 HOURS OF ACUTE MYOCARDIAL
INFARCTION”
Objective Of The Study
To study the pattern of Arrhythmias over 48 hours following Acute Myocardial Infarction. MR/MS______,I request you to enroll yourself in the study conducted by Dr. ATIF AHMED. S,Post graduate student in M.D General Medicine under the guidance of Dr.S.VISHWESHWARAN,Professor, Dept. Of General Medicine, K.V.G. Medical College, Sullia, D.K.
Your participation in research is voluntary, your decision whether or not to participate will not affect your relationship with at K.V.G. Medical College and hospital. The purpose of research is tostudy the pattern of arrhythmias occurring following Acute Myocardial Infarction.
Procedure Involved
If you agree to participate in this research study, we would ask you to answer a questionnaire and undergo routine investigations, ECG,ECHO & Cardiac Monitoring for 48 hours.
Risks and benefits:
There may be risks involved in treatment, if any complication occurs during the study, you will be treated best of our knowledge. There is no compensation or payment for such medical treatment.
Alternatives
Even if you decline in participation, you will get the routine line of management.
Privacy and confidentiality:
The only people to know that you are a research subject are members of the research team, No information about you or provided by you during the research will be disclosed to others without your written permission except:
1. In emergency to protect your rights and welfare.
2. If required by Law.
Authorization to publish results:
When the results of the research are published or discussed, in a conference, no information will be displayed that would disclose your identity. Any information that is obtained in connection with this study and that can be identified with you will remain confidential.
Financial Incentives For Participation
You will not be paid / offered any free gifts for participation in the research, you will not be reimbursed for expenses
INFORMED CONSENT FORM
I, the undersigned ______have been explained in my own vernacular language, about the study and that my participation in study is voluntary.
I have been explained about the risks involved in the study and have been given enough time to clear my doubts and rights as study participant.
In case I have questions related to the study, I have been asked to contact
Dr.ATIF AHMED. S. (Mobile No: 9964155816)
Signature or the left thumb print of participant or legally authorized representative
Participants name ______Signature______
Witness name ______Signature______
Investigator’s name______Signature______
Date______
Place______
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