From,

Dr.Vishnu Sharma

Department of Pulmonary Medicine

A.J. Institute of Medical Sciences,

Mangalore- 575004

To,

The Member Secretary,

Ethical committee A.J.I.M.S,

  1. J. Institute of Medical Sciences,

Mangalore- 575004

Through,

Dr.Vishnu Sharma

Professor and Head Department of Pulmonary Medicine

A.J.I.M.S

Respected sir,

Subject: Submission of Synopsis of Dissertation for Ethical Committee Clearance.

Herewith, I am forwarding the synopsis of the dissertation work of Dr.Bibin Jose, Postgraduate Resident in the department of Pulmonary Medicine, titled : “CARDIOVASCULAR DISEASES IN COPD PATIENTS” for ethical committee clearance of A.J. Institute of Medical Sciences.

Kindly accept the same and oblige.

Signature of the head of the departmentThanking you,

( Dr. Vishnu sharma)

Dr.Vishnu Sharma

Signature of the Postgraduate

(Dr.BibinJose)

Place: Mangalore

Date: 19-09-2011

From,

Dr. Bibin Jose

Post Graduate in Department of Pulmonary Medicine

  1. J. Institute of Medical Sciences,

Mangalore- 575004

To,

The Member Secretary,

Ethical Committee A.J.I.M.S,

A.J. Institute of Medical Sciences,

Mangalore- 575004

Respected sir,

Subject: Submission of Synopsis of Dissertation for Ethical Committee Clearance.

Herewith, I am submitting synopsis of my dissertation work:“CARDIOVASCULAR DISEASES IN COPD PATIENTS” for Ethical Committee clearance of A.J. Institute of Medical Sciences, Mangalore

Enclosed here with the copies of:-

Synopsis of dissertation

Curriculum vitae of guide

Curriculum vitae of candidate

Kindly accept the same and oblige.

Thanking you,

Yours faithfully,

(Dr.BibinJose)

Place: Mangalore

Date: 07-08-2012

From,

Dr. Bibin Jose

Post Graduate student in Department of Pulmonary Medicine

A.J. Institute of Medical Sciences,

Mangalore- 575004

To,

The Registrar,

RajivGandhiUniversity of Health Sciences,

Bangalore

(Through proper channel)

Sub: Submission of Synopsis of Dissertation

Respected Sir,

Herewith, I am submitting synopsis of my dissertation work“CARDIOVASCULAR DISEASES IN COPD PATIENTS” for the registration in Rajiv Gandhi University of Health Sciences, Bangalore.

Kindly accept the same and oblige.

Thanking you,

Yours faithfully,

(Dr.Bibin Jose)

Place: Mangalore

Date: 07-08-2012

CURRICULUM VITAE

Name: DR. VISHNU SHARMA .M.

Date Of Birth & Age:May 17, 1970

Present Designation:Professor & HOD

Department:Pulmonary Medicine

College:A.J. Institute of Medical Sciences

City :Mangalore

Residential Address:SANTHRUPTHI, Battagudda

Nodu Lane

Bejai,Mangalore

Phone & Fax Number With Code:Office :0824-2225533

Residence :0824-2216321

E- Mail Address:

Mobile Number :9448126321

Date Of Joining Present Institution:Jan 14, 2004 as Associate Professor

2. Qualification

Qualification / College / University / Year / Registration No. Of UG & PG With Date / Name Of The State Medical Council
M.B.BS / KozhikodeMedicalCollege, / Calicut University / Mar, 1993 / 39,862, Dt Nov 21,1994 / Karnataka Medical Council
MD (T.B & Resp. Diseases) / Jawaharlal Institute Of Post-Graduate Medical Educ, & Research / PondicheryUniversity / Mar, 1998 / 39,862, Dt Nov 21,1994 / Karnataka Medical Council
D.N.B / National Board Of Examinations, New Delhi / May 1998 / 21829 Dt. Dec 29,1999 / T.C. Medical Council

3. Details Of The Previous Appointments/ Teaching Experience

Designation / Department / Name of Institution / From DD/MM/YY / To DD/MM/YY / Total Experience In Years & Months
PG Resident / TB & Chest / Jawaharlal Institute Of Post – Graduate Medical Education And Research Pondicherry / Apr 03, 1995 / Mar 31,1998 / 3 Years.
Assistant Professor / TB & Chest / KasturbaMedicalCollege, Mangalore / Nov 16,1998 / Sep 15,1999 / 10 Months
Assistant Professor / TB & Chest / K.SHegdeMedicalAcademy, Mangalore / Sep 16,1999 / Jan 13,2004 / 4 Years 4 Months
Associate Professor / TB & Chest / A.J Institute Of Medical Sciences, Mangalore / Jan 14,2004 / Feb 29,2008 / 4 Years 2 Months
Professor & Head / TB & Chest / A.J Institute Of Medical Sciences, Mangalore / March 1,2008 / Till Date

CURRICULAM VITAE

Name: DrBibinJose

Date of birth:05-03-1985, 27years

Present designation:PG Junior Resident

Department:Pulmonary Medicine

College:A.J Institute of Medical Science

City:Mangalore

Nature of appointment:Full Time

Whether belongs to:Others

Present Address of employee:Alcel villa,

Kuntikana,Mangalore

Date Of Joining Present Institution :June 15,2012 as PG Junior resident

Academic qualifications:

Qualification / College / University / Year / Registration No. Of UG & PG With Date / Name Of The State Medical Council
MBBS / Dr.Somerwell Memorial Medical College, Karakonam,
Trivandrum / Kerala University / 2010 / 43838 / Travancore Cochin Medical Council
DM/M. Ch / NA / NA / NA / NA / NA

3. Details Of The Previous Appointments/ Teaching Experience

Designation / Department / Name of Institution / From DD/MM/YY / To DD/MM/YY / Total Experience In Years & Months
PG/Junior Resident / Pulmonary Medicine / A.J Institute of medical
science Mangalore / June 15, 2012 / Till date

RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE.

ANNEXURE II

SYNOPSIS FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 / NAME OF THE CANDIDATE AND ADDRESS / DR.BIBIN JOSE
POSTGRADUATE STUDENT
DEPT OF PULMONARY MEDICINE
A.J.INSTITUTE OF MEDICAL SCIENCES
MANGALORE- 575004
2 / NAME OF THE INSTITUTION / A.J.INSTITUTE OF MEDICAL SCIENCES
MANGALORE
3 / COURSE OF STUDY AND SUBJECT / MD COURSE IN PULMONARY MEDICINE
4 / DATE OF ADMISSION TO COURSE / 15 JUNE 2012
5 / TITLE OF THE TOPIC / CARDIOVASCULAR DISEASES IN COPD PATIENTS
6 / BRIEF RESUME OF INTENDED WORK:
6.1. NEED FOR THE STUDY:
Chronic Obstructive Pulmonary Disease and Cardiovascular diseases coexist in many patients due to similar risk factors which include smoking, age etc..Hence the study about the incidence and prevalence of the different cardiovascular diseases in COPD patients can help in managing these patients.
6.2.REVIEW OF LITERATURE:
CHRONIC OBSTRUCTIVE PULMONARY DISEASE:
Chronic obstructive pulmonary disease (COPD), a common preventable and treatable disease, is characterized by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lungs to noxious particles or gases. Exacerbations and co morbidities contribute to the overall severity in individual patients.
Worldwide the most commonly encountered risk factor for COPD is tobacco smoking. In many countries,outdoor,occupational and indoor air pollutionare also major risk factors for COPD.
A clinical diagnosis of COPD should be considered in any patient who has dyspnoea, chronic cough or sputum production, with a history of exposure to risk factors for the disease. Diagnosis of COPD should be confirmed by Spirometry.
COPD remains a majorpublic healthproblem all over the world. It is the fourth leading cause of chronicmorbidity and mortality in the United States.COPD is projected to rank five in 2020 in burden of disease worldwide. Despite being a common disease COPD remainsrelatively unknown by the public and is considered a less serious health issue by medical fraternity.
According to the latest WHO estimates (2004), currently 64 million people
have COPD and 3 million people died of COPD. WHO predicts that COPD will become the third leading cause of death worldwide by 2030.
Reference-Eur Resp J 2008;31;204-212
COPD is associated with chronic heart failure (CHF) in about 20% of patients. There is overwhelming evidence from large scale epidemiological studies that impaired forced expiratory volume in one second is a powerful marker of morbidity and mortality decrease in FEV1 has direct correlation with increased cardiovascular mortality.Interestingly,increased arterial stiffness is also related to the severity of airflow obstruction and may be a factor in the excess risk of developing cardiovascular disease in COPD.Patients with severe COPD have elevated circulating levels of C-Reactive protein (CRP).A working hypothesis to account for the high prevalence of left ventricular systolic dysfunction in COPD patients is that low grade systemic inflammation accelerates progression of coronary atherosclerosis which ultimately results in ischemic cardiomyopathy.Such a hypothesis fits the clinical observation of a high incidence of left ventricular wall motion abnormalities in patients with COPD and left ventricular dysfunction.
CARDIOVASCULAR DISEASES IN COPD
Reference-CHEST 2005;128(4);2640-2646
Ischemic heart diseases including Myocardial Infarction, Ventriculardysfunctions, Congestive Cardiac Failure, trial and Ventricular arrhythmias and fibrillations, Pulmonary and Coronary thrombo embolism, and Cardiomyopathies are the common disorders seen in COPD patients.
6.3. AIMS & OBJECTIVES OF STUDY
1.To find the incidence of cardiovascular diseases in COPD patients.
2. To find out the cardiac disease pattern in COPD patients.
7 / MATERIALS AND METHODS:
SOURCE OF DATA AND METHOD OF COLLECTION
Patients coming to the OPD with the symptoms suggestive of COPD will be taken into the study. Diagnosis of COPD is confirmed by spirometry.All these patients will be enquired regarding any cardiac symptoms. A detailed respiratory and cardiac examination will be done and findings noted. Chest’ X ray’, ECG and ECHO will be done for all the patients. Patients with coexisting lung disease, chest wall abnormalities, and pleuraldisease will be excluded from the study.
8 / LIST OF REFERENCES:
  1. Cardiovascular morbidity and mortality in COPD-Journal CHEST 2005,128(4) pgs 2640-2646
  1. Prevalence and outcomes of Diabetes, Hypertension and cardiovascular disease in COPD-European Respiratory Journal Oct.2008 vol.32 no.4 pgs 962-969
  2. COPD and incident cardiovascular disease hospitalization and mortality-Journal CHEST-Oct 2005 Vol.128(4) pgs 2068-2075
  1. Cardiovascular risk in COPD-Journal-RESPIROLOGY vol 12 Issue Sept.2007 pgs 634-641
  1. C Reactive protein & mortality in mild to moderate COPD-Journal THORAX 2006,61 pgs 849-853
  1. Increased risk of Myocardial Infarction and stroke following exacerbation of COPD-Journal CHEST May 2010 vol.137 no.

9 / SIGNATURE OF CANDIDATE:
10 / REMARKS OF THE GUIDE:
11 / NAME AND DESIGNATION OF:
11.1.GUIDE / Dr. VISHNU SHARMA
PROFESSOR AND HEAD OF DEPARTMENT
DEPARTMENT OF PULMONARY MEDICINE
A.J.INSTITUTE OF MEDICAL SCIENCES
KUNTIKANA, MANGALORE – 575004
11.2. SIGNATURE
11.3. COGUIDE: ----
11.4. SIGNATURE:----
11.5. HEAD OF THE DEPARTMENT: / Dr. VISHNU SHARMA
PROFESSOR AND HEAD OF DEPARTMENT
DEPARTMENT OF PULMONARY MEDICINE
A.J.INSTITUTE OF MEDICAL SCIENCES
KUNTIKANA, MANGALORE – 575004
11.6. SIGNATURE:
12 / 12.1.REMARKS OF THE CHAIRMAN AND PRINCIPAL:
12.2.SIGNATURE OF THE PRINCIPAL:

PROFORMA

  1. Name of the subject
  2. age:
  3. sex:
  4. weight:
  5. Detailed history regarding respiratory and cardiac diseases
  6. Past history:
  7. Current medications:
  8. Smoking history in detail:
  9. COPD diagnosed and on treatment for how many years?
  10. Clinical Examination findings
  11. Spirometry
  12. Chest X-ray
  13. ECG
  14. ECHO findings, Cardiac enzyme markers if feasible
  15. Cardiovascular disease present
  16. Complete Diagnosis

Written Informed Consent Form

A J INSTITUTE OF MEDICAL SCIENCES,

KUNTIKANA, MANGALORE.

Informed consent form for the patient/subjects who will be participating in the research project (MD dissertation) entitled: “CARDIOVASCULAR DISEASES IN COPD PATIENTS”

Name of Principal Investigator / Dr.Bibin Jose,
Postgraduate student
Name of Organization / Department of Pulmonary Medicine,
A J Institute of Medical Sciences, Kuntikana, Mangalore

This Informed Consent Form has two parts:

  • Information Sheet (to share information about the research with you)
  • Certificate of Consent (for signatures if you agree to take part)

You will be given a copy of the full Informed Consent Form

PART I: Information Sheet

Introduction:

I, Dr.Bibin Jose, post graduate resident in the department of Pulmonary Medicine, A.J.Institute of Medical Sciences, Kuntikana, Mangalore, is working on my M.D dissertatation work “CARDIOVASCULAR DISEASES IN COPD PATIENTS”.My study subjects will be the whole lot of COPD patients who come to our Medical College hospital both on OP as well as IP basis in a period of 1.5 to 2 years which is expected to amount to about 3000 to 5000.There may be some words that you do not understand. Please ask me to stop as we go through the information and I will take time to explain. If you have question later, you can ask and get yourself clarified.

Voluntary Participation

Your participation in this research is entirely voluntarily. It’s your choice whether to participate or not.

Procedures and Protocol..

To find out the cardiovascular diseases, if any, in the COPD patients by means of clinical examination,ChestX-ray,ECG & ECHO and compare withtheir occurrence in individuals without COPD.

Duration :The study will be over in one day.

Benefits

Although it can help to find out the underlying cardiovascular diseases also, through a proper evaluation and check up, personally you won’t be benefited in any way directly from the research. But by taking part in the research, you will be helping the scientific world to learn more about the parameters which are used in the study.

Reimbursements

You will not be given any other money or gifts to take part in this research.

Confidentiality

The information that we collect from this research project will be kept confidential. Information about you that will be collected during the research will be put way and no one but the researchers will be able to see it. Any information about you will have a number on it instead of your name.

Sharing the Results

Confidential information will not be shared. We will publish the results in order that other interested people may learn from our research.

Right to Refuse or Withdraw

You do not have to take part in the research if you do not wish to do so. You may also stop participating in the research at any time you choose. It is your choice and all of your rights will still be respected.

Whom to Contact.

This proposal has been reviewed and approved by the research and Ethical committee of A.J.Institute of Medical Sciences, Kuntikana, Mangalore, which is a committee whose task is to make sure that research participants are protected from harm.

You can ask me any more questions about any part of the research study, if you wish to. Do you have any questions?

1.

2.

PART-II Certificate of Consent

I have read the fore going information, or it has been read to me. I have had the opportunity to ask questions about it and any questions that I have asked have been answered to my satisfaction. I consent voluntarily to participate as a participant in this research.

Print name of the Participant:………………..

Signature of participant......

Date......

Day/ month/ year.

If illiterate a literate witness must sign (if possible, this person should be selected by the participant and should have no connection to the research team). Participants who are illiterate should include their thumb print as well.

I have witnessed the accurate reading of the consent form to the potential participant, and the individual has had the opportunity to ask questions. I confirm that the individual has given consent freely.

Print name of witness...... AND Thumb printof participant

Signature of witness......

Date......

Day/month/ year.

Statement by the researcher / person taking consent.

I have accurately read out the information sheet to the potential participant, and to the best of my ability made sure that the participant understands that the following will be done:

1.

2.

3.

I confirm that the participant was given an opportunity to ask questions about the study and all the questions asked by the participant have been answered correctly and to the best of my ability. I confirm that the individual has not been forced into giving consent, and the consent has been given freely and voluntarily.

A copy of this informed consent form has been provided to the participant.

Name of researcher / person taking the consent......

Signature of researcher / person taking the consent......

Date......

Day/ month/ year.