"STUDY OF ELECTROCARDIOGRAPHIC CHANGES IN ACUTE STROKE IN A RURAL HOSPITAL"
SYNOPSIS OF DISSERTATION SUBMITTED TO
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
In partial fulfillment of regulations for the award of
M.D. Degree in General Medicine
Submitted by
Dr. NAMEIRAKPAM DHANACHAND SINGH . M.B.B.S.
POST GRADUATE STUDENT IN
GENERAL MEDICINE (M.D.)
Under the guidance of
Prof Dr. MOHAN M.E., M.B.B.S., M.D.,
PROFESSOR AND HEAD,
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
2011
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. NAMEIRAKPAM DHANACHAND SINGH
P.G. IN GENERAL MEDICINE,
A.I.M.S., B.G. NAGARA,
MANDYA DISTRICT -571448
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 / 30TH JUNE 20115. / TITLE OF THE TOPIC / “STUDY OF ELECTROCARDIOGRAPHIC CHANGES IN ACUTE STROKE IN A RURAL HOSPITAL”
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 METHODS
7.1 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
/ Doctors must know the various manifestations of ECG in acute stroke in a patient with normal heart. This rural hospital has got all the facilities to mange stroke. ECG gives clues regarding various forms of stroke Hence, the study has been taken up in this rural hospital.11. / 11.1 NAME OF THE GUIDE / Dr. MOHAN M.E. M.B.B.S, M.D.
PROFESSOR & HEAD,
DEPARTMENT OF GENERAL MEDICINE,
A.I.M.S, B.G.NAGARA.
11.2 SIGNATURE OF THE GUIDE
11.3 CO-GUIDE (IF ANY) / Dr. VENUGOPAL KRISHNA. K.S.
M.B.B.S, M.D. D.M. (NEUROLOGY)
ASSOCIATE PROFESSOR,
DEPARTMENT OF GENERAL MEDICINE,
A.I.M.S, B.G.NAGARA.
11.4 SIGNATURE
11.5 HEAD OF DEPARTMENT / Dr. MOHAN M.E. M.B.B.S, M.D.
PROFESSOR & 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. M.B.B.S., M.D.
PRINCIPAL,
AIMS, B.G. NAGARA.
12.2 SIGNATURE
APPENDIX-I
6.BRIEF RESUME OF THE INTENDED WORK:
APPENDIX –I A
6.1 NEED FOR THE STUDY:
Most cerebrovascular diseases are manifested by the abrupt onset of a focal neurologic deficit, as if the patient was "struck by the hand of God." A stroke, or cerebrovascular accident, is defined by this abrupt onset of a neurologic deficit that is attributable to a focal vascular cause.1
Cerebrovascular diseases occur predominantly in middle and late years of life and also a small proportion in young age. They cause approximately 2,00,000 deaths in United States every year as well as considerable neurologic disability.1
The prevalence of stroke in India was estimated as 203 per 100,000 population above 20 years, amounting to a total of about 1 million cases. The male to female ratio was 1.7. Around 12% of all stroke occurred in population below 40 years.2 It was estimated that stroke represented 1.2 % of the total deaths in the country, when all ages were included. The proportion of stroke death increased with age, and in the oldest group (> 70 years of age) stroke contributed to 2.4% of all deaths.3
A comparative study of stroke between India and other countries showed that Indians are more susceptible to stroke.4 The proportion of strokes in the young is significantly more in India than in developed countries; some of the more important causes for this are likely to be rheumatic heart disease, ischemic strokes in peripartum period and arteriopathies as a sequelae of CNS infections like bacterial and tuberculosis, meningitis and meningitis vascular syphilis.5
Many studies have shown close relationships between cerebrovascular accident and cardiovascular diseases. Physicians have known for centuries that primary cardiac disorders an lead to stroke, but the realization that stroke may produce cardiac abnormalities is much more recent.6
The patients with signs of stroke and with an abnormal ECG represents a common diagnostic challenge to the clinician. ECG changes can occur due to existing cardiac diseases. Cerebrovascular accident can cause abnormal ECG even in patients without heart disease.7
ECG changes affecting t-wave, u-wave, ST segment, QT interval and various arrhythmias have been reported.
The ECG changes in subarachnoid hemorrhage and intra cranial bleeding may resemble those of myocardial ischemia and sometimes acute myocardial infarction and misinterpretation has led to delay in operative treatment for subarachnoid hemorrhage. Operation on an intra cranial aneurysm may be postponed or an unduly grave prognosis given if it is wrongly believed that ECG indicates a fresh change of myocardial infarct.8
In view of the above speculations, the objective of the present study is to identify the electrocardiographic changes produced primarily due to cerebrovascular accidents.
APPENDIX –I B
6.2 REVIEW OF LITERATURE
Historical aspects
It has been know from over 60 years that brain lesions may be accompanied by abnormalities in electrocardiograph - works done by Aschenbrenner and Bodechtel in 1938 reveals this. Later in 1947 Byer et al reported tall upright T-waves and prolonged QT interval in a patient with subarachnoid hemorrhage. Striking changes in electrocardiograph in patients suffering from subarachnoid hemorrhage have been documented since then. In 1953 Levine referred to cascading T-waves which become replaced by RS-T segment elevation in a patient who had a ruptured aneurysm of the circle of willis.9
Burch, Meyers and Abildskov (1954) found 10 abnormal electrocardiographs among cerebrovascular accident admission to a Louisiana hospital during the year 1950. Common abnormalities were prolonged QT interval, T-waves of increased amplitude and duration and sometimes large U-waves.10
The first necropsy confirmation of extra cardiac origin of electrocardiographic changes in cerebrovascular accidents was done by Crop et al, in 1956.
Cropp and Manning in 1960 reported electrocardiographic changes in stroke are due to the neural influences rather than actual myocardial damage.11
Knusen and Curb in 1988 studied predictive value of electrocardiographic abnormalities in Honolulu heart programme. They found that ST depression, left ventricular strain, T wave inversion are the major abnormalities detected.12
Oppenheimer in 1990 reported that Qt prolongation, T wave flattening or inversions, ST segment alterations are most commonly seen after subarachnoid hemorrhage and intracerebral hemorrhage.13
Davis T.P. in 1993 in his study of ECG changes in cerebrovascular accidents says that acute vascular disorders of central nervous system cause disturbance of rhythm and morphology of electrocardiograph.14
Lindgren in 1994 conclude that STT changes are seen in about half case of stroke pateints without primary heart disease.15
Negrusz Kawecka M in 1998 opined that in patients with hypertension associated with stroke showed more incidence of premature supraventricular beats and ill sustained ventricular tachycardia.16
Kocan M.J. in 1998 concluded ECG changes result from an imbalance in autonomic nervous system resulting in a relative access of sympathetic activity.17
Mayer in 1999 noticed that electrocardiographic abnormalities and elevations of creatinine kinase and creatinine kinase MB are most commonly found in subarachnoid hemorrhage.18
Sahoo P in 2000 found that ST – T wave changes was the commonest change in electrocardiograph associated with stroke. They concluded that electrocardiographic changes are more common in hemorrhagic stroke and carry bad prognosis.19
Abnormalities, such as ischemic-like ECG changes and/or QT prolongation, were found in 76% (95% CI 73-90) of patients with subarachnoid hemorrhage, irrespective of whether they had preexisting heart disease or not. Thus, in patients with subarachnoid hemorrhage, repolarization and ischemic-like ECG changes are mainly direct consequences of the cerebral condition and their absence essentially rules out cardiac abnormalities. In patients with ischemic stroke and intracerebral hemorrhage, these ECG abnormalities (and QT prolongation) most often represent preexisting coronary artery disease.20
It has been suggested that lesions in the insula may result in abnormal electrocardiographic (ECG) findings and increase the risk of sudden death. Insular lesions were related to sinus tachycardia with heart rate >120bpm(p=0.001), ectopic beats >10%(p=0.032), and ST elevation (p=0.011). Right insular lesion were related to atrial fibrillation (p=0.009), atrioventricular block(p=0.029), ectopic beats>10%(p=0.016), and inverted T wave(p=0.040).21
Golan S, Livneh A found out that in a patient, who presented with left sided hemiparesis and right frontal brain infarction, ischemic-like new T wave inversion appeared in a routine electrocardiogram (ECG), performed 2 days after admission.22
Electrocardiographic ST–T changes with or without troponin, CK-MB positivity are frequent clinical entities in patients with acute ischemic stroke.23
Elevated troponin level after acute stroke is common and is associated with ECG changes suggestive of myocardial ischemia and increased risk of death.24
Significant tachycardia and bradycardia are frequent phenomena in acute stroke; however they do not independently predict clinical course or outcome. Continuous monitoring allows detecting rhythm disturbances in stroke patients and allows deciding whether urgent medical treatment is necessary.25
APPENDIX –IC
6.3 AIMS AND OBJECTIVES OF STUDY
a) To study the electrocardiographic changes seen in patients with acute stroke who are not suffering from any primary cardiac diseases.
b) To study the nature of electrocardiographic changes seen in patients with different types of stroke.
APPENDIX-II
7.0 MATERIALS AND METHODS
APPENDIX-IIA
7.1 SOURCE OF DATA:
The study will consist of patients with stroke admitted to Sri Adichunchanagiri hospital and Research Centre, B.G. Nagara, Bellur during the period from November 2011 to May 2013.
APPENDIX-IIB
7.2 METHOD OF COLLECTION OF DATA
To record relevant clinical history with particular reference to prodromal symptoms, mode of onset, evolution of neurological disease and a thorough clinical and physical examination performed with special emphasis to nervous system and cardiovascular system as per the proforma. To enquire particularly symptoms of valvular heart disease, rheumatic heart disease and ischemic heart disease.
Study period : November 2011- May 2013
Sample size : Minimum number of 100 cases will be studied after applying the inclusion and exclusion criteria to the number of stroke patients admitted in AIMS Hospital over a period of 2 years.
INCLUSION CRITERIA:
a) Cases with cerebrovascular accidents within 24 to 48 hours.
b) Cases admitted in the hospital for more than 7 days for follow up to be done.
c) Individuals without any primary cardiac diseases.
d) Cases with no hepatic or renal disorders that will induce circulatory, metabolic and electrolyte imbalances.
e) Age and sex - Individuals with age > 18 years and both male and female sex.
EXCLUSION CRITERIA:
a) Cases of head injury.
b) Cases who came 72 hours after stroke.
c) Individuals with known cardiac diseases have been excluded.
d) Those with hepatic or renal disorders which are known to induce circulaturory, metabolic and electrolyte imbalances.
STATISTICAL METHODS :
The data obtained will be analyzed by descriptive statistics by means of percentage, proportions, age and depicted via bar charts, pie charts.
TYPE OF STUDY:
Observational and analytical study.
APPENDIX-IIC
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 Complete hemogram with peripheral smear
o Serum Electrolytes – Sodium, potassium, chloride
o FBS, PPBS, RBS
o Lipid profile
o Blood urea
o Serum creatinine
o Liver function test if needed
o Serum Albumin
o Urine routine
o Echocardiography
o Chest X- ray pa view
o Lumbar puncture
o C.S.F. examination – Cell type, cell count, malignant cells, microscopy, sugar, protein, tension, colour, xanthrochromia
o CT scan
o ECG – Within 24 hours of admission, 3rd day and 7th day.
o Other relevant investigations.
APPENDIX-IID
PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL
SECTION A
a / Title of the study / “STUDY OF ELECTROCARDIOGRAPHIC CHANGES IN ACUTE STROKE IN A RURAL HOSPITAL”b / Principle investigator
(Name and Designation) / Dr. NAMEIRAKPAM DHANACHAND SINGH
P.G. IN GENERAL MEDICINE,
A.I.M.S., B.G. NAGARA,
MANDYA DISTRICT –571448
c / Co-investigator
(Name and Designation) / Dr. MOHAN M.E. M.B.B.S, M.D.
PROFESSOR & HEAD,
DEPARTMENT OF GENERAL MEDICINE,
A.I.M.S, B.G.NAGARA.
d / Name of the Collaborating
Department/Institutions / NA
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 ICSection – D
Methodology / APPE NDIX IIBA / Where the proposed study will be undertaken / ADICHUNCHANAGIRI HOSPITAL AND RESEARCH CENTRE, B.G.NAGARA
B / 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
I. Will they be institute students?
II. Will they be institute employees?
III. Will they be Paid?
IV. If they are to be paid, how much per session? / NO
NO
NO
NA
E / Is the study a part of multi central trial? / NO
F / If yes, who is the coordinator?
(Name and Designation)
Has the trial 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
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 / NA
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
IV. Duration of Employment / NO
NO
NO
NA
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 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.