Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore.
Annexure – II
Proforma for Registration of TOPIC for dissertation
1. / Name of the Candidate & Address / : / Dr. SWARAJ S.WADDANKERI.Dept. of Medicine
M. R. Medical College
Gulbarga 585 105
S/o Dr. SHRIKANT S.W.
H. No. 10-105/3/1
“Anugraha”
Sharan Nagar
Gulbarga 585 103
2. / Name of the Institution / : / H.K.E. Society’s
Mahadevappa Rampure Medical College, Gulbarga
3. / Course of Study and Subject / : / M.D. (General Medicine)
4. / Date of Admission to Course / : / 1st June 2007
5. / Title of the Topic / : / “Plasma C-reactive protein levels as a prognostic and diagnostic marker in first ever acute ischemic stroke”
6. / Brief Resume of the Intended Work
6.1 Need for the study
Stroke is a global epidemic and an important cause of mortality and morbidity. It is the third leading cause of death in India after cardiovascular diseases and cancer.
“India will face an enormous socio economical burden to meet the cost of rehabilitation of stroke victims owing to increased life expectancy and urbanization”
1880 stroke victims die everyday due to stroke, which is 22 times of death of malaria and 1.4 times that of tuberculosis.1
In the U.K. the incidence is 1.5/1000/year third commonest cause of death in UK.
In the USA stroke causes 2,00,000 deaths each year and is a major cause of disability.2
The main stress in stroke patients is to detect it very early and prevent the future complications. There are various biomarkers used in the early detection of stroke, of these, the acute phase reactant, C Reactive Protein (CRP) is one of them.
CRP plays an important role in early diagnosis and exerts an even more important role as a prognostic indicator for both mortality and morbidity.
This study aims at measuring plasma CRP levels between 12-72 hrs of onset of symptoms of stroke, as a prognostic and diagnostic indicator for acute ischemic stroke.
Here patients admitted to the hospital for an acute ischemic stroke are prospectively investigated with CT scan of brain for confirming the infarction.
6.2 Review of Literature
Muir KW et al (1999) studied elevated concentration of acute phase reactant CRP predicts ischemic cardiac and cerebral events in both population and hospital based studies. They concluded that CRP concentration is an independent predictor for inflammation in acute ischemic stroke.3
Ridker PM et al (2001) compared various risk factors for systemic atherosclerosis – CRP, fibrinogen, homocysteine, lipoprotein (a) and standard cholesterol as a predictors of peripheral arterial disease and came to an opinion that of the 11 atheroembotic biomarkers assessed at baseline, the total cholesterol–High Density Lipoprotein (HDL) ratio and CRP were the strongest independent predictors of development of peripheral arterial disease. CRP provided additive prognostic information over standard lipid measures.4
Mahapatra SC et al (2002) studies the role of CRP in the pathogenesis of ischemic stroke and their study revealed a positive correlation between persistent increase of CRP titer and ischemic stroke and CRP>6mg/dl was considered as a positive study group.5
J. David Curb et al (2003) studied CRP levels in middle aged healthy men as a risk factor of thromboembolic stroke and opined that increased CRP in middle adulthood and in men with healthier risk factor profile may be as important as a risk factor for thromboembolic stroke.6
Christensen H and Boysen G (2004) were of the opinion that levels of white blood cells (WBC) and CRP increase within the first 24-hour in patients with severe stroke. CRP but not WBC is related to long term mortality possibly by reflecting the vascular risk profile.7
Arevalo-Lorido JC, Carretero-Gomez J et al (2005) found that increased levels of CRP in the non-favorable stroke category that was related with neurological and functional disabilities and radiological findings mainly when the levels were greater than 3.6mg/dl.8
Di Napoli et al (2005) studied CRP levels in acute ischemic stroke and found that in secondary prevention of stroke, elevated CRP levels added to the existing prognostic markers.9
L. Massoti et al (2005) studied CRP levels as a prognostic indicator in very old patients with acute ischemic stroke and concluded that increased values at hospital admission could represent a negative prognostic index in elderly patients with ischemic stroke, in particular for short term prognosis.10
6.3 Objectives of the Study
1. To observe plasma CRP levels in acute ischemic stroke
2. To evaluate the role of CRP as a prognostic and diagnostic aid in acute ischemic stroke
3. To evaluate CRP level as a risk factor in acute ischemic stroke
7. / Material and Method
7.1 Source of data
Patients presenting with acute ischemic stroke admitted in Basaveshwar
Teaching and General Hospital, attached to Mahadevappa Rampure Medical college, Gulbarga.
7.2 Methods of collection of data
Study subjects: 50 cases of acute ischemic stroke admitted during the period of January 2008 to June 2009 in Basaveshwar Teaching & General Hospital, Gulbarga.
Controls: 50 controls will be selected from the patients admitted in other wards in the hospital, matched with study subjects in all possible factors except the disease under study.
Timing of measuring CRP levels: The plasma CRP levels will be measured anytime between 12 to 72 hours of onset of symptoms.
Follow up: Follow up done up to hospital stay.
Inclusion Criteria
1. Age group between 20 – 80 years
2. Patients with either or both type 2 diabetes mellitus and hypertension
3. Ischemia proved by CT scan brain, in all cases of the study
Exclusion Criteria
1. Age less than 20 years and more than 80 years
2. Patients with history of heart disease – any valvular heart disease, infective endocarditis, myocardial infarction.
3. Patients with previous h/o stroke or transient ischemic attack
4. Patients with collagen vascular diseases, active tuberculosis, arteritis
5. Patients with haemorrhagic stroke or subarachnoid hemorrhage
6. Patients with any malignant growth
7. Patients with meningitis, brain abscess or any chronic infection that affects CRP levels
8. Patients with h/o head injury within the past 3 months
7.3 Does the study require any investigation or interventions to be conducted on patients or other humans or animals ? If so, please describe briefly.
Yes, the study requires investigations like -- Hb%, total count, differential count, ESR, blood urea, serum creatinine, urine routine and microscopy, RBS, FBS, and PPBS, ECG, 2D ECHOcardiography, Serum triglycerides, LDL–cholesterol, HDL–cholesterol, collagen vascular studies, CT scan - Brain.
7.4 Has ethical clearance been obtained from your institution in case of 7.3
Yes, ethical clearance has been obtained from the Ethical Committee of the Institution.
8. / List of References
1. Mishra NK, Patel H, Hastak SM; “Comprehensive Stroke Care - An overview”; JAPI; Jan 2006; 54;36-41
2. Kasper, Braunwald, Fauci, Hauser, Jameson, Harrisons Principle of Internal Medicne; 16th Edn; 2372 Mac Graw Hill
3. Mahapatra RC et al; “C reactive protein in thrombotic stroke”; JAPI; Dec 2002; 50:1512
4. Muir KW, Weir CJ, Alwan W, Squire IB, Lees KR; “C reactive protein and out come after ischaemic stroke”; Stroke 1999; 30; 981-985
5. Ridker PM, Stampfer MJ, Rifai N; “Novel risk factors for systemic atherosclerosis - a comparison of CRP , fibrinogen , homocystein, lipoprotein(a) and standard cholesterol screening as predictors of peripheral arterial disease”; JAMA; May 2001; 16; 285(19); 2481-2485
6. Curb JD, Abbott RD, Rodriguez BL, Sakkinen P, Popper JS, Yano K, et al; “C-Reactive Protein and the Future Risk of Thromboembolic Stroke in Healthy Men” Circulation 2003; 107; 2016
7. Christensen H, Boysen G; “C-reactive protein and white blood cell count increases in the first 24 hours after acute stroke” Cerebrovasc Dis. July 2004; 18(3); 214-219
8. Arevalo-Lorido JC, Carretero-Gomez J, Calvo-Romero JM, Romero-Requena JM, Perez-Alonso JL, Gutierrez-Montano C. et al; “C Reactive Protein in the acute phase of ischemic stroke” Med Clin (Barc); Dec. 2005; 125(20); 766-769
9. Di Napoli, Schwaninger M, Cappelli R, Ceccarelli E, Gianfilippo GD, Donati C, et al; “Evaluation of C-Reactive Protein Measurement for Assessing the Risk and Prognosis in Ischemic Stroke” Stroke 2005; 36; 1316
10. Massotti L, Ceccacelli E, Forconi S, Capelli R; Journal of Internal Medicine 2005; 258; 145-152
9. / Signature of Candidate / :
10. / Remarks of the Guide / :
11. / Name and Designation of / :
11.1 Guide / : / Dr. BHARAT KONIN, M.D.D.M.{NEUROLOGY}
ASSOCIATE Professor
Department of MEDICINE
Mahadevappa Rampure Medical College, Gulbarga.
11.2 Signature / :
11.3 Co-Guide (If Any) / : / --
11.4 Signature / : / --
11.5 Head of the Department / : / Dr. VEERANNA, M.D.D.M.{CARDIOLOGY}
Prof. & Head
Department of Biochemistry
Mahadevappa Rampure Medical College, Gulbarga.
11.6 Signature / :
12. / 12.1 Remarks of the Chairman & Principal / :
12.1 Signature / :