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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE. ANNEXURE-II

1. NAME OF THE DR.HAMSA M CANDIDATE AND #7421, 1ST CROSS, ADDRESS SUBASHNAGAR,NELAMANGALA, BANGALORE - 562123.

ADDRESS FOR DR. HAMSA M CORRESPONDENCE PG IN BIOCHEMISTRY DEPT OF BIOCHEMISTRY MANDYA INSTITUTE OF MEDICAL SCIENCES, MANDYA- 571401.

2. NAME OF THE MANDYA INSTITUTE OF MEDICAL SCIENCES, INSTITUTION MANDYA- 571401.

3. COURSE OF THE STUDY M.D. BIOCHEMISTRY AND SUBJECT

4. DATE OF ADMISSION TO 31-08-2013 THE COURSE

5. TITLE OF THE TOPIC CROSS SECTIONAL STUDY TO DETERMINE THE RISK FACTORS OF CARDIOVASCULAR DISEASE IN PATIENTS WITH PSORIASIS IN MEDICAL COLLEGE HOSPITAL, MANDYA.

6. Brief resume of intended work. 6.1. Introduction and need for the study: Psoriasis is a common inflammatory and immune-mediated skin disease affecting 2-3% of population worldwide1. It is characterized by abnormal proliferation of keratinocytes and infiltration of immune cells, predominantly T cells and dendritic cells in psoriatic lesions. The activation of T cells produces cytokines. These cytokines play an important role in the pathogenesis of psoriasis, leading to increased proliferation of keratinocytes2, 3.

Psoriasis is characterised by redness, thickening and scaling of the skin. These characteristics are used to assess severity of psoriasis by using the Psoriasis Area and Severity Index (PASI) scoring, which is the gold standard method 4.

Psoriasis may cause significant morbidity due to the co- existence of psoriatic arthritis and associated systemic diseases. It is associated with increased occlusive vascular disease including cardiovascular risk factors such as obesity, smoking, dyslipidemia, hypertension, and diabetes. There is an increased risk of myocardial infarction (MI) in patients with psoriasis, accounting for major cardiovascular risk. These are said to coexist due to common inflammatory pathways5,6.

‘ Risk factor’ refers to an attribute or characteristic or exposure of an individual whose presence or absence raises the probability of an adverse outcome8.

There are various disease-specific and non-disease- specific risk factors modifying one another in worsening the disease condition often leading to incomplete management of the disease among psoriasis patients. Hence, it becomes important to study these risk factors that predispose the psoriasis patients to co morbidities such as cardiovascular diseases and diabetes mellitus.9

Hence this study is being conducted to determine the risk factors of cardiovascular diseases in patients with psoriasis. 6.2. Review of literature:

In a study conducted by Wu Y, psoriasis patients were more likely to have cardiovascular co morbidities, including hypertension, hypercholesterolemia compared with patients with no psoriasis10.

In a study conducted by Späh F , cardiovascular disease is an important cause of morbidity and mortality in patients with psoriasis, as it is associated with an increased cardiovascular risk profile like arterial hypertension, coronary heart disease, hyperlipidaemia, obesity and type 2 diabetes, which are more prevalent in them than in control patients11.

In a study conducted by Gisondi P on psoriasis and atherothrombotic diseases, disease-specific and non-disease- specific risk factors, the presence of cardio-metabolic co morbidities has relevant implication in the therapy and global approach to patients with psoriasis. Traditional systemic antipsoriatic agents frequently reduce cardio-metabolic co morbidities and may have important interactions with drugs commonly used by psoriasis patients. Thus, patients with psoriasis should be treated effectively and encouraged to aggressively correct their modifiable cardiovascular risk factors9. According to Ayala F in the study titled ‘ Clinical aspects and co morbidities of psoriasis’, people with moderate to severe psoriasis have more risk for cardiac disease, presumably due to the inflammatory nature of psoriasis, causing inflammatory changes in coronary arteries12.

Batya B et al in their study on Psoriasis and Systemic Inflammatory Diseases suggested that metabolic aspects of chronic Th-1 and Th-17 inflammation in psoriasis have the potential to impact other conditions such as obesity, diabetes, and atherosclerosis. Conversely inflammatory molecules and hormones produced in conditions such as obesity, diabetes and atherosclerosis may influence the pathogenesis of psoriasis by promoting proinflammatory state, which increases the susceptibility to the development of psoriasis or severity of established psoriasis13.

In a review on metabolic co morbidities and psoriasis by Gisondi P et al. Patients with psoriasis show an increased risk of atherothrombotic diseases independently of the concomitance of traditional cardiovascular risk factors14.

In a study on cardiovascular comorbiditiy in psoriasis by Singh G et al, psoriasis is associated with co morbidities that include metabolic syndrome and increased cardiovascular risk. These conditions share etiologic features and health consequences that directly correlate with the severity of psoriasis15. In a case control study on cardiovascular and metabolic risk profile in German patients with moderate and severe psoriasis by Warnecke C et al. patients with psoriasis had significantly increased prevalence of smoking, obesity, diabetes, insulin resistance, pro- atherogenic cholesterol profiles and myocardial infarction and significantly decreased cardio protective adiponectin16.

According to survey on Psoriasis co morbidities by Armstrong AW et al. in patients with severe psoriasis there is an increased odds of psoriatic arthritis, diabetes and cardiovascular diseases compared to those with mild-to-moderate psoriasis17.

Updated review on cardiovascular aspects of psoriasis by Pietrzak A et al. suggested that the treatment of the inflammatory processes involved in the pathogenesis of both psoriasis and atherosclerosis may be beneficial in reducing the cardiovascular risk in psoriatic patients18.

In a systematic literature review of cardiovascular morbidity and mortality in psoriasis and psoriatic arthritis by Horreau C et al. there may be a small, but significant increased risk of cardio vascular events, but not of cardio vascular mortality in psoriasis and Psoriatic arthritis patients19. 6. 3. Objective of the study:

1. To determine biochemical risk factors of cardio vascular disease in psoriasis. 2. To determine the behavioral risk factors of cardio vascular disease in psoriasis.

7. Materials and methods:

7.1. Source of data:

Study setting: The study will comprise the cases of psoriasis visiting the outpatient Department of Dermatology at the teaching hospital of Mandya Institute of Medical Sciences, Mandya.

Study design: Cross sectional study.

Study period: 1 year from June 2014 to May 2015.

7.2. Method of collection of data:

Study will be initiated after obtaining approval from the Institutional Ethics Committee of Mandya institute of Medical Science, Mandya. Written informed consent will be taken from the study subjects, after explaining to them the plan and intention of the study in the language best known to them. Physical measurements which include height, weight, Body Mass Index and blood pressure will be recorded.

Under strict aseptic precaution 2 – 3 ml of venous blood will be collected by venepuncture, in each of the non vacuum EDTA tube and non vacuum plain tube with clot activator. These blood/serum samples will be tested for the below listed biochemical parameters-

1. Fasting blood glucose level by GOD- PAP methodology.

2. Total cholesterol by CHOD- POD methodology.

3. Serum Triglycerides by GPO Peroxidase methodology.

4. HDL by Direct determination (enzyme selective protection method).

5. LDL by Friedwald’s calculation in samples where the total cholesterol is less than 400mg/dl.

6. HbA1c by Nephelometry methodology

7. Complete Blood Count by automatic cell counter.

Inclusion Criteria:

1. Patients with clinical diagnosis of psoriasis who have given written consent to participate in the study.

2. Both males and females.

Exclusion Criteria:

1. Age group <18 yrs. 2. Pregnant and lactating females. 3. Recent history of blood transfusion. 4. Patients with severe anemia ( Hb < 8mg/dl)18. 5. Patients not willing to take part in the study. 6. Patients with acute illness.

Statistical Analysis:

The collected data will be entered in an Excel sheet and analysed using Epi-info/SPSS software and descriptive statistics, such as ‘chi-square’ test, t’ test and any other statistical test will be used as applicable.

7.4. Does the study require any investigations or interventions to be conducted on patients or other humans or animals?

Yes, physical measurements and biochemical investigations

Physical Measurements

Height (cm) measured using stadiometer.

Weight (kg) measured by analog weight scale.

2 2 Body Mass Index (kg/m ) calculated using formula weight/height .

Waist Circumference (in cm) measured by measuring tape.

Blood Pressure (mmhg) measured using sphygmomanometer.

Investigations

1. Fasting Blood Glucose by GOD- PAP methodology.

2. Total cholesterol by CHOD- POD methodology.

3. Serum Triglycerides by GPO Peroxidase methodology.

4. HDL by Direct determination (enzyme selective protection method). 5. LDL by Friedwald’s calculation in samples where the total cholesterol is less than 400mg/dl.

6. HbA1c by Nephelometry methodology

7. Complete blood count by automatic cell counter.

7.5. HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION?

Yes, obtained. 8. Bibliography .

1. National Psoriasis Foundation. Psoriasis Statistics. Available from: https://www.psoriasis.org/learn_statistics acessed on 05/11/2013. 20.00 hrs.

2. Stern RS, Nijsten T, Feldman SR et al. Psoriasis is common, carries a substantial burden even when not extensive, and is associated with widespread treatment dissatisfaction. J Investig Dermatol Symp Proc 2004; 9: 136–9.

3. Krueger JG, Bowcock A. Psoriasis pathophysiology: Current concepts of pathogenesis. Ann Rheum Dis 2005; 64: ii30–6.

4. Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis 2005; 64:ii65–8.

5. Ghazizadeh R., Shimizu H., Tosa M., Ghazizadeh M. Pathogenic mechanisms shared between psoriasis and cardiovascular disease. Int. J. Med. Sci 2010; 7: 284-9. 6. Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB, Gelfand JM. Prevalence of cardiovascular risk factors in patients with psoriasis. J Am Acad Dermatol. 2006: Nov; 55(5): 829-35.

7. Ghaffar A, Reddy KS, Singhi M. Burden of non-communicable diseases in South Asia. BMJ. 2004 april 13; 328(7443); 807-10.

8. World Health Organization. http://www.who.int/topics/risk_factors/en/, accessed on 12/11/2013. 13.20 hrs. 9. Gisondi P, Girolomoni G. Psoriasis and atherothrombotic diseases: disease-specific and non-disease-specific risk factors. Semin Thromb Hemost. 2009 Apr; 35(3): 313-24. doi: 10.1055/s-0029-1222610. Epub 2009 May 18.

10. Wu Y, Mills D. Psoriasis: cardiovascular risk factors and other disease comorbidities. J Drugs Dermatol. 2008 Apr; 7(4): 373- 7.

11. Späh F. Inflammation in atherosclerosis and psoriasis: common pathogenic mechanisms and the potential for an integrated treatment approach. Br J Dermatol. 2008 Aug; 159 Suppl 2: 10- 7.

12. Ayala F, Ayala F. Clinical aspects and comorbidities of psoriasis. J Rheumatol Suppl. 2009 Aug; 83: 19-20. doi: 10.3899/jrheum.090214.

13. Davidovici BB, Sattar N, Prinz C, Jo¨rg, Puig L, Emery P, Jonathan N. Barker et al. Psoriasis and Systemic Inflammatory Diseases: Potential Mechanistic Links between Skin Disease and Co-Morbid Conditions. Journal of Investigative Dermatology (2010) 130, 1785–1796.

14. Gisondi P, Ferrazzi A, Girolomoni G. Metabolic Comorbidities and Psoriasis. REVIEW. Acta Dermatovenerol Croat 2010; 18(4): 297-304.

15. Singh G and Aneja SPS. Cardiovascular co morbidity in psoriasis. Indian J Dermatol. 2011 Sep-Oct; 56(5): 553–556.

16. Warnecke C, Manousaridis I, Herr R, Terris DD, Goebeler M, Goerdt S, Peitsch WK. Cardiovascular and metabolic risk profile in German patients with moderate and severe psoriasis: a case control study. Eur J Dermatol. 2011 Sep-Oct; 21(5): 761- 70. doi:10.1684/ejd.2011.1467.

17. Armstrong AW, Schupp C, Bebo B. Psoriasis comorbidities: results from the National Psoriasis Foundation surveys 2003 to 2011. Dermatology. 2012; 225(2): 121-6. doi: 10.1159/000342180. Epub 2012 Oct 26.

18. Pietrzak A, Bartosińska J, Chodorowska G, Szepietowski JC, Paluszkiewicz P,Schwartz RA. Cardiovascular aspects of psoriasis: an updated review. Int J Dermatol. 2013 Feb; 52(2): 153-62. doi: 10.1111/j.1365-4632.2012.05584.x

19. Horreau C, Pouplard C, Brenaut E, Barnetche T, Misery L, Cribier B et al. Cardiovascular morbidity and mortality in psoriasis and psoriatic arthritis: a systematic literature review. J Eur Acad Dermatol Venereol. 2013 Aug; 27 Suppl 3: 12-29. doi: 10.1111/jdv.12163. 20. World Health Organization. Hemoglobin concentrations for the diagnosis of anemia and assessment of severity. Available from http://www.who.int/vmnis/indicators/haemoglobin.pdf. Accessed on 12/11/2013. 10.20 hrs. SIGNATURE OF THE CANDIDATE

THE TOPIC CHOSEN IS RELEVANT AND 10 REMARKS OF THE GUIDE JUSTIFIED.

11 NAME AND DESIGNATION OF

DR. RAGHUNATH H ASSISTANT PROFESSOR DEPARTMENT 11.1 GUIDE OF BIOCHEMISTRY. MANDYA INSTITUTE OF MEDICAL SCIENCES, MANDYA-571 401 SIGNATURE 11.2

DR. HARISH.M.R PROFESSOR AND HOD 11.3 CO GUIDE DEPARTMENT OF DERMATOLOGY MANDYA INSTITUTE OF MEDICAL SCIENCES, MANDYA- 571401

11.4 SIGNATURE DR.MAHADEVA.S.K IN-CHARGE HOD, 11.5 HEAD OF THE DEPARTMENT DEPARTMENT OF BIOCHEMISTRY. MANDYA INSTITUTE OF MEDICAL SCIENCES, MANDYA-571 401

11.6 SIGNATURE

12

12.1 REMARKS OF DEAN AND PRINCIPAL

12.2 SIGNATURE WRITTEN CONSENT FORM

Subject Title: CROSS SECTIONAL STUDY TO DETERMINE THE RISK FACTORS OF CARDIOVASCULAR DISEASE IN PATIENTS WITH PSORIASIS IN MEDICAL COLLEGE HOSPITAL, MANDYA Subjects Name: Age: Gender: IP/OP no: Address

(i) I have been explained about the study in detail in the language I understand, and I have clarified all my doubts.

(ii) I understand that my participation in the study is voluntary and that I am free to withdraw from the study at any time, without giving any reason, without my medical care or legal rights being affected.

(iii) I agree not to restrict the use of any data or results that arise from this study provided such a use is only for scientific purpose(s)

(iv) I agree to take part in the above study on my own will.

.

Signature of the subject/ left thumb impression Date .

Signature of the witness Date

.

Signature of the investigator

Date

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INFORMED CONSENT TAKEN(Y/N):

SOCIODEMOGRAPHIC DATA NAME: AGE: GENDER: IP/OP NO: OCCUPATION: SOCIO ECONOMIC STATUS

HISTORY OF PSORIASIS:

DURATION OF PSORIASIS: TYPE: FAMILY HISTORY: ASSOCIATED COMPLICATIONS: TREATMENT: DURATION OF TREATMENT: TYPE OF TREATMENT: DOSAGE: RESPONSE TO TREATMENT:

PASI SCORE:

HISTORY OF ASSOCIATED COMORBIDITIES ARE YOU A KNOWN a) DIABETIC(Y/N) b) HYPERTENSIVE(Y/N) IF YES FOR ONE OR MORE DIABETES HYPERTENSION a)SINCE HOW LONG b) IF ON TREATMENT AND SINCE WHEN?

ANY PREVIOUS HISTORY OF CORONARY HEART DISEASE? IF YES a) WHEN WAS THE LAST EPISODE? b) IF ON TREATMENT.

ANY HISTORY OF PROLONGED ILLNESS? IF YES a) SINCE HOW LONG? b) IF ON TREATMENT:

BEHAVIORAL MEASUREMENTS 1) ARE YOU A SMOKER? IF YES, a) SINCE WHEN? b) HOW MANY BIDIS/CIGARETTES PER DAY? 2) DO YOU CONSUME ALCOHOL? IF YES, a) SINCE WHEN? b) HOW OFTEN AND HOW MUCH?

PHYSICAL MEASUREMENTS 1) HEIGHT( in centimetres) 2) WEIGHT(in kilograms) 3) BODY MASS INDEX(in kg/m2) 4) WAIST CIRCUMFERENCE(in centimetres) 5) BLOOD PRESSURE(in mm hg)-

BIOCHEMICAL MEASUREMENTS DATE AND TIME OF BLOOD SAMPLE COLLECTION- 1) HbA1C (in %): 2) FASTING BLOOD SUGAR(in mg/dl): 3) TOTAL CHOLESTEROL (in mg/dl): 4) SERUM TRIGLYCERIDES (in mg/dl): 5) SERUM HDL CHOLESTEROL (in mg/dl):

COMPLETE BLOOD COUNT 1. HEMOGLOBIN (g/dl) 2. TOTAL COUNT(Thousand/cu.mm): 3. DIFFERENTIAL COUNT (%): 4. RED BLOOD CELL(mil/cu.mm):

Estimated average glucose by formula: eAG(mg/dl) = (28.7 X HbA1c) – 46.7

SERUM LDL by Friedwald’s equation (in mg/dl):

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