Proforma for registration of subject for dissertation

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Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore


PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION


  1. Name of candidate and address: DR.AMRUTA ANIL PANDIT

Post graduate student,

Department of Pharmacology,

St. John’s Medical College.



  1. Name of Institution: St. John’s Medical College, Bangalore



  1. Course of study and subject: M.D., Pharmacology



  1. Date of admission to course: 25/03/2010



  1. Title: Drug treatments in post- myocardial infarction arrhythmias: a prospective, follow- up study in a tertiary- care centre.



  1. Brief resume of the intended work:



    1. Need for study

Globally ischemic heart disease is one of the leading causes of morbidity & mortality. Developing countries account for 80% of the burden.1

Cardiac arrhythmias, particularly ventricular tachy-arrythmias, 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.1 In older patients, atrial fibrillation is frequently associated with CVD. Atrial fibrillation and atrial flutter have been associated with embolism, stroke, heart failure and frequent hospitalizations in these patients. No data are available from India to date on the prevalence of post- MI arrhythmias, its treatments and outcomes.

Adequate management of cardiac arrhythmias is crucial in curbing mortality and long term morbidity. Several drugs are available in the management of arrhythmias. Little is known in India on the rates and patterns of drug used in the management of post-MI arrhythmias.

The present study therefore intends to estimate the in-hospital prevalence of post MI arrhythmias, its presentation, treatments and outcomes.


    1. Review of literature

After a decline in the incidence of communicable diseases, presently, a rapid rise is seen in the incidence of non- communicable diseases. At the dawn of the third millennium, the prevalence of non- communicable diseases is rising across the globe. It is predicted that, by 2020, non-communicable diseases will cause 70% of deaths in developing countries.2 Among non-communicable diseases, the major diseases are cardiovascular disease (ischemic heart disease- IHD and hypertension), diabetes, cancer and chronic pulmonary disease.2 The burden of these conditions affects countries worldwide but with a growing trend in developing countries. Diabetes and hypertension, apart from other disabilities, can lead to IHD. Incidence of IHD has been on the rise and IHD has become one of the leading causes of morbidity & mortality. About 8,00,000 people in the United States are affected by myocardial infarction and in spite of a better awareness of manifesting symptoms and better healthcare facilities, 2,50,000 patients die annually.3 In a country like India4, where health care access is not equitable, MI results in significant morbidity and mortality.

The risk factors for AMI include lipid disorders, diabetes, hypertension, use of tobacco, family history of MI etc.3 of the role of these risk factors in causing post MI arrhythmias is unclear among Indians.

MI could potentially result in the following complications-3


  • Ischemic (including failure of reperfusion): angina, reinfarction, infarct extension

  • Mechanical: heart failure, cardiogenic shock, mitral valve dysfunction, aneurysms, cardiac rupture
  • Arrhythmic: atrial or ventricular arrhythmias, sinus or atrioventricular (AV) node dysfunction


  • Thrombosis and embolic: central nervous system or peripheral embolisation

  • Inflammatory: pericarditis

  • Psychosocial complications, including depression

Cardiac arrhythmias is one of the important causes of morbidity and mortality post MI.1 A life-threatening arrhythmia, e.g. ventricular tachycardia, ventricular fibrillation and total atrioventricular (AV) block, may be the first manifestation of ischemia or infarction. Ventricular fibrillation or sustained ventricular tachycardia has been reported in up to 20% of patients.5 Though ventricular tachyarrythmias are important after an MI, as age advances, atrial arrhythmias are also commonly encountered.1

Many drugs are available in the management of post MI arrhythmias. Drug management of arrhythmia depends on the type of arrhythmia, patient’s condition and whether patient has any disease or drug contraindicating the use of most appropriate drug. The currently available antiarrhythmic drugs can be classified by the Vaughan Williams 4-level schema6 as-



  1. Class I: fast sodium channel blockers.

1A: Eg. Procainamide, quinidine, disopyramide

1B: Eg. Lidocaine, mexiletine

1C: Eg. Flecainide, propafenone, moricizine


  1. Class II: beta blockers. Eg. Propranolol, esmolol

  2. Class III: repolarization potassium current blockers. Eg. Amiodarone, dofetilide, ibutilide

  3. Class IV:calcium channel antagonist. Eg. Verapamil, diltiazem

The most commonly used drugs clinically are:

A. Beta Blockers: These drugs are effective in suppressing ventricular ectopic beats and arrhythmias as well as reducing sudden cardiac death (SCD) in a spectrum of cardiac disorders in patients with and without

heart failure (HF). Beta blockers are safe and effective

antiarrhythmic agents that can be considered the mainstay

of antiarrhythmic drug therapy.

B. Amiodarone: It has been used commonly in suppressing ventricular arrhythmias, but the clear benefit of the drug in improving survival is still under question.

C. Intravenous procainamide, amiodarone, lidocaine: They are the drugs used in the management of stable, monomorphic ventricular tachycardia (VT).6




Newer drugs in the treatment of arrhythmias: Dronedarone

Dronedarone is a derivative of amiodarone that is free of iodine and is less lipophilic. The drug has – as its predecessor – multichannel-blocking efficacy and in addition vasodilating effects. Dronedarone has undergone thorough clinical evaluation in various patient populations. The drug was shown to postpone the recurrence of atrial fibrillation after cardioversion relative to placebo. Dronedarone is now approved by the FDA for treatment of nonpermanent atrial fibrillation to reduce the risk of cardiovascular hospitalization.7

Drug utilization studies are carried out to assess current rates of drug use and the outcomes, to compare the treatment with the standard treatment guidelines. It was defined by WHO in 19778 as the marketing, distribution, prescription and use of drugs in society with special emphasis on the resulting medical, social and economic consequences. The main aim of drug utilization studies is to evaluate the rationality of the treatments and generate evidence for use of most appropriate drugs. Many drug utilization studies have been done nationally and internationally under different settings. They can be undertaken to explore the use of a particular drug/ group of drugs9 or assess the overall use of drugs in various populations.10Although many drug utilization studies have been carried out in India in the last decade11, details about studies directed towards exploring drug use in cardiac arrhythmias are lacking.

In the management of any illness, patients’ Quality of Life is an increasingly important parameter to assess. Hence assessing and quantifying the Quality of Life of patients becomes another important point of study.


    1. Objectives of the study


1. To determine the in hospital prevalence, demography and presentation of cardiac arrhythmias.

2. To assess the pattern and rates of drug- use and its determinants.

3. To compare the treatment with the AHA/ACC.3

4. To estimate the outcomes in patients in the hospital and at 6 months and study the barriers to providing optimal patient care.



  1. Material and methods



    1. Source of data

  1. Study site: Study will be conducted at the Cardiac ICU, cardiology wards in a tertiary care hospital.

  2. Study subjects: Patients with myocardial infarction with documented cardiac arrhythmia on ECG.

  3. Sample size: Patients admitted to hospital with a diagnosis of MI with arrhythmia satisfying the inclusion criteria will be included. In the year 2009 (January 2009- December 2009) about 80 patients with post- MI arrhythmias were admitted. So based on this data, we anticipate recruiting about 100 patients in the 18 month study period (accounting for the patients who refuse consent or those fulfilling exclusion criteria).

  4. Study design: Prospective, observational, hospital based study.

  5. Duration of study: 18 months

  6. Inclusion criteria:

Patients with documented MI based on two of the following three criteria:



  1. Patients in whom a clinical diagnosis of MI was made based upon typical signs and symptoms; previous history of ischemic heart disease.

  2. ECG findings suggesting STEMI(ST segment elevation myocardial infarction) or NSTEMI(Non- ST segment myocardial infarction).

  3. Elevated cardiac markers (Creatinine phosphokinase, troponin-T).


WITH

Any one of the following findings on ECG during present admission:



  1. Atrial fibrillation/ flutter

  2. Fast ventricular rate

  3. Ventricular tachycardia/ fibrillation

  4. Various degrees of heart blocks (1st, 2nd or 3rd degree)



  1. Exclusion criteria:

  1. Patients treated elsewhere and referred to this hospital for further management without adequate and reliable information on prior treatments received.

  2. Those in whom the six month follow-up is not possible(eg. Patients from a far-off place or with mental disorders).

7.2 Method of collection of data:

Using a structured case report form, we will collect the following data:

On admission:

  1. Demographic and socio- economic data

  1. Age

  2. Gender

  3. Habits

  4. Socio- economic status: education, income, occupation, property

  1. Medical history

  1. Past medical history

  2. Time to reach the hospital from the onset of first symptoms

  1. Quality of drug use in the hospital

  1. Selection of drug

  2. Dose given to the patient

  3. Route of administration

  4. Duration of treatment

  5. Adverse drug reactions

  6. Drug interactions

  1. Outcomes
  1. Conversion to sinus rhythm or control of ventricular rate (rhythm or rate control)


  2. Any other morbidity

  3. Mortality

On discharge:

  1. Medications prescribed

  2. Quality of life of the patient

On follow- up at six months:

  1. Patient Outcomes

  2. Quality of life

Statistical analysis:

Categorical variables will be compared by chi-squared tests. Continuous variables will be presented as the mean value +/-2SD and compared using the Student t test. A p value <0.05 will be considered significant for all teats. Statistical analyses will be performed using commercially available software(SPSS).

7.3 Does the study require investigations or interventions to be conducted on patients or other humans or animals? No.

7.4 Has ethical clearance been obtained from your institution? Applied for approval.



  1. List of references



  1. Nitish Naik, Rakesh Yadav, Rajnish Juneja. Epidemiology of arrhythmias in India: how do we obtain reliable data? Current Science 10 August 2009; Vol.97(No.3): 411-415.

  2. Abdesslam Boutayeb. The double burden of communicable and non-communicable diseases in developing countries. The Transactions of the Royal Society of Tropical Medicine and Hygiene March 2006; Vol. 100(3): 191-199.

  3. ACC/AHA Guidelines for the Management of Patients with Acute Myocardial Infarction: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Acute Myocardial Infarction). Joint American College of Cardiology 34: 1999; 890-911.
  4. Xavier D, Pais P, Devereaux PJ, Xie C, Prabhakaran D, Reddy KS et al . CREATE :A prospective analysis of registry data. Lancet 2008; 371: 1435–42.


  5. Frans Van de Werf, Jeroen Bax, Amadeo Betriu, Carina Blomstrom-Lundqvist, et al. Management of acute myocardial infarction in patients presenting with ST- segment elevation. EHJ 2008; 29:2909-2945.

  6. ACC/AHA/ESC 2006 Guidelines for Management of Patients With

Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death:A Report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines. Circulation 2006;114;1088-1132.

  1. Duray, Gabor Z; Ehrlich, Joachim R; Hohnloser, Stefan H. Dronedarone: a novel antiarrhythmic agent for the treatment of atrial fibrillation. Current Opinion in Cardiology January 2010; 25(1): 53–58.

  2. Introduction to drug utilization research / WHO International Working Group for Drug Statistics Methodology,WHO Collaborating Centre for Drug Statistics Methodology, WHO Collaborating Centre for Drug Utilization Research and Clinical Pharmacological Services, 2003.

  3. Quan Zhou, Ling-Ling Zhu, Xiao-Feng Yan, Wen-Sheng Pan, Su Zeng. Drug utilization of clarithromycin for gastrointestinal disease treatment. World Journal of Gastroenterology 2008 October 21; 14(39): 6065-607.




  1. Signature of the candidate



  1. Remarks of the guide



  1. Name and designation of



    1. SIGNATURE

    1. GUIDE: Dr. Denis Xavier


Professor and Head,

Department of Pharmacology,

St. John’s Medical College.



    1. SIGNATURE



    1. CO- GUIDE: Dr. Kiron Verghese, MD DM,

Professor,

Department of Cardiology,

St. John’s Medical College Hospital.



    1. SIGNATURE



    1. HEAD OF DEPARTMENT: Dr. Denis Xavier

Professor and Head,

Department of Pharmacology,



St. John’s Medical College.



    1. Remarks of the chairman and principal



    1. Signature


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