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1 ST PhD PROGRESS PRESENTATION (Jun 2016- Nov 2016)

1 ST PhD PROGRESS PRESENTATION (Jun 2016- Nov 2016). Title of the study: Coronary artery dimensions, myocardial bridging and their role in coronary artery disease among four states of South India. Divia Paul A PhD Scholar (Reg no.152/Jan 2015) Department of Anatomy

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1 ST PhD PROGRESS PRESENTATION (Jun 2016- Nov 2016)

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  1. 1ST PhD PROGRESS PRESENTATION (Jun 2016- Nov 2016) Title of the study: Coronary artery dimensions, myocardial bridging and their role in coronary artery disease among four states of South India Divia Paul A PhD Scholar (Reg no.152/Jan 2015) Department of Anatomy Yenepoya Medical College Yenepoya University Co-Guide: Dr. Subramanyam.K H.O.D Department of Interventional Cardiology K.S Hegde Medical Academy Hospital Guide: Dr. Ramakrishna Avadhani Professor & H.O.D Department of Anatomy Yenepoya Medical College Yenepoya University

  2. Introduction and background • Coronary artery vessels size varies among individuals and there is an evidence of some degree of variability among different geographic regions. • The calibre of coronary arteries, both main stems and larger branches, ranges between 1.5 to 5.5 mm at their origins. This is based on measurements of arterial casts or angiograms. • The diameters of the coronary arteries may increase up to the 30th year of life. (Standring S et al., 2008) • The associated details about calibre of coronary artery among the Indian population are limited.

  3. Contd... • The present study will help to reveal whether the ethnic variation of artery size holds ground. • The present study provide the first step towards developing a quantitative estimate of coronary artery by correlating it with gender differences and body mass index among population of South India. • The present study correlates the body mass index and coronary artery dimensions to find out any association between them to be a precursor for coronary artery disease (CAD).

  4. Contd... • Myocardial bridging (MB) has been implicated in coronary artery disease and there is lack of clarity as to whether MB actually has a significant role to play in coronary artery disease (CAD). • Studies regarding this aspect have not shown consistent result as their sample sizes have been small. This study will aid in providing reliable data to study this association. • Cardiac dominance patterns and their correlations with atherosclerotic prominence give a better understanding of itsclinical significance. • The present study outlooks the incidence percentages of right, left and co-dominance patterns in a broader aspect.

  5. LITERATURE SURVEY • CORONARY ARTERY DIMENSION AND VARIATIONS: STUDIES IN DIFFERENT GEOGRAPHICAL AREAS • International scenarios • The South Asians showed the evidences of smaller proximal left anterior descending (LAD) luminal diameters, higher mean percent stenosis per vessel and number of subjects with double or triple vessel disease when compared to Caucasians at a similar period of time in the United States of America. (Hasan RK et al., 2011)

  6. National scenarios • Comparisons of normal dimensions of the coronary artery segments in Indian population with western estimates implied that coronary artery dimensions for at least some branches of the left coronary system are similar and of the right coronary appears greater in Indian population. These conclusions repudiate the general impression that Indians have smaller coronary arteries.(Saikrishna C et al., 2006) • The prevalence of risk factors for CAD in an urban Indian population is high. Therefore, there is an urgent need to raise awareness of these risk factors ,so that individuals at high risk for future CAD can be managed effectively. (Sekhri T et al., 2014)

  7. Local scenarios • The prediction of normal coronary dimensions may overcome the ineptitudes of judging the percentage stenosis in diffusely fragmented coronary artery diseases.(Sankar V et al., 2005) • An increased prevalence of coronary artery disease (CAD) in South Indian population has been reported from chennai, with supporting study evidence. (Mohan V et al., 2001)

  8. MYOCARDIAL BRIDGING AND ITS IMPORTANCE • Myocardial bridging has a prevalence of 5% to 12% among patients and is usually confined to the left anterior descending (LAD).(Alegria JR et al., 2005) • The surrounding myocardium initiates an idiosyncratic atheroprotective hemodynamic microenvironment within bridges even though the mechanisms induced for this initiation uniqueness are largely unknown.(Chatzizisis YS et al.,2009)

  9. BODY MASS INDEX: RISKS AND CUT-OFF VALUES – GENDER, RACE DIFFERENCES • The current cut-off point recommended by WHO for body mass index (BMI) is ≤25 kg/m2 for not being overweight and ≤30 kg/ m2 for not being classified as obese. (WHO Expert Consultation. Lancet., 2004) • Gender significantly impacts coronary artery dimensions which can explain some gender-related risk with coronary artery revascularization, accentuating the priority of considering multiple subsidizing factors. (Dickerson JA et al., 2010)

  10. CARDIAC DOMINENCE • The right coronary artery (RCA) is dominant in 85% of patients and nondominant in 15% of patients in which the left circumflex artery (LCx) is the dominant vessel. The remaining patients have balanced or co-dominant circulation. (Mann DL et al., 2014) • The coronary artery system was right dominant in 76%, left dominant in 9.1% and co-dominant in 14.8% of the cases. (Kosar P et al., 2009)

  11. SOCIAL RELEVANCE OF THE STUDY • The present study helps to acquire precise knowledge of the expected normal lumen diameter at a given coronary anatomic location which could be more useful than the traditional percent stenosis assessments. • Coronary stenting in the treatment of patients with small vessels isstill a causative factor for recurrent restenosis in patients. • The study helps the interventional cardiologists and cardiac surgeons to treat the patient by a bed to needle approach rather than a bed to scalpel approach. • The study may also help them not to merely presume the artery size with a concept of ethnic variation.

  12. Contd... • The size of the coronary artery with or without a myocardial bridge (MB) may have a major role to play in the causation of coronary artery disease (CAD). • Cardiac dominance patterns and their correlations with atherosclerotic prominence give a better understanding of its clinical significance. • This could further aid in changing the approach of intervention on the patients, which in turn may help the patient to return to a normal life faster than the routine restrictions and precautions after a coronary bypass surgery. • Surgical procedures could be avoided. All these would lead to lower cost of coronary care, faster recuperation, and better quality of life for the patients; both physically and economically.

  13. Aim of the study To study the coronary artery vessel size with and without myocardial bridging and its association with other pre-selected factors causing coronary artery disease among South Indian population.

  14. Objectives of the study i. To assess coronary vessel morphology in patients with and without myocardial bridging. ii. To find if gender differences exist among coronary artery measurements. iii. To find the possible association of body mass index with vessel dimensions. iv. To find the distribution of normal and tunneledsegments among diseased and non-diseased coronary arteries. v. To find an association between cardiac dominance and artery stenosisinvolvement.

  15. Methods and Materials i. Study Design: A cross sectional study will be conducted. ii. Study Setting: • In order to get the correct representation of the South Indian population, all four states will be used for data collection. • Hospitals will be selected according to the number of cardiac patients identified by them. • The collection of samples depends upon the report of sanction for the same from ethical committee of the preselected hospitals. • More number of hospitals from each state will be included if sufficient samples are not achieved under stipulated period .

  16. Contd… iii. Hospitals selected for the study are: 1. K.S Hegde Medical Academy, Derlakkatte, Mangalore, Karnataka.  2. Amrita School of Medicine, Ponnekkara, Kochi, Kerala. 3. Madras Medical Mission Hospital, Chennai, Tamilnadu. 4. Care hospital , Hyderabad, Andhra Pradesh. iv. Study subjects: • Patients who visit the cardiology outpatient department as a part of their routine cardiac checkups will be selected as study subjects, if they undergo a coronary angiography procedure due to variation in the normal cardiac parameters. • The selection criteria to be enrolled for a coronary angiography procedure will be strictly subjected to the guideline protocols.

  17. Contd… INCLUSION CRITERIA: • All patients who undergo angiogram procedure as a part of their routine diagnosis will be selected for the study purpose after obtaining informed consent. • The criterion is strictly subjected if the patients are of Indian origin and from the respective state. • For this history of the patient origin need to be enquired and cross checked with patient details from respective files. EXCLUSION CRITERIA: • Patients with congenital heart disease, rheumatic heart disease, and cardiomyopathies will be excluded from the study. • Patients with previous history of myocardial infarction and recanalisednormal looking coronary arteries will also be exclu- ded.

  18. Contd… v. Sample size and its calculation • Four thousand samples are estimated statistically for conducting the study. Sample size determination • Minimum sample size required is 3855 cases. Taking the sample size as 4000 as the samples can be up to 10% more than of the estimated sample size. • Level of significance = 5% • Effect size = 0.015 • Prevalence =12%(Alegria JR et al., 2005) • The sample size was estimated by consulting a statistician and using the statistical software G* Power 3.0.10. • The estimated sample size has to be divided by four as the study is conducted in four South Indian states =4000/4=1000 cases per state.

  19. Contd… vi. Sampling technique  • Convenience sampling will be done as all eligible cases which fulfil the inclusion criteria during the definite time period of the study will be selected as samples. • Patients will be approached at the cath lab prior to angiogram procedure.

  20. PLAN OF STUDY

  21. METHODOLOGY A. ETHICAL CONSIDERATIONS B. ANGIOGRAPHY PROCEDURE a. Preparation of the patient b. Vascular Access c. Catheters d. Selection Criteria for Target Vessels e.Angiographic projections f. Angiogram reports C. CALCULATION OF BODY MASS INDEX D. DATA COLLECTION E. INDIVIDUAL SEGMENT MEASUREMENT ASSESSING PATTERNS

  22. INTRA CORONARY CATHETER Figure 1: Intracoronary catheter

  23. STATISTICAL ANALYSIS • Statistical analysis will be done using the SPSS software package for Windows version 22.0 (SPSS Inc., Chicago, IL) or a higher version based on the availability at the time of data analysis. • Descriptive statistics will be used to present the socio-demographic data. • Mean/ median/ mode with respective intervals will be used to measure vessel dimensions and percentages used to present categorical data. • Independent variables: Gender, myocardial bridging, cardiac dominance, Body mass Index (BMI ). • Dependent variables: Coronary vessel size, Coronary artery disease.

  24. Contd… • Appropriate parametric and / or non-parametric tests of significance for metric and categorical data will be used for observing and documenting an association between independent and dependent variables. • t-test, Pearsons correlation, and ANOVA will be used for metric data. Chi-square and logistic regression test will be used for categorical data. • Correlations will be estimated by Pearson correlation coefficient. A p-value less than 0.05 will be considered as statistically significant.

  25. i. Out-come of research work: • Sample collection: Ongoing process of sample collection, data analysis and its interpretation from K.S Hegde Medical Academy, Deralakatte, Mangalore, Karnataka.

  26. A CHANGE IN A WORD IN THE AIM OF STUDY : details of amendment • To study the coronary artery vessel size with and without myocardial bridging and its association with other pre-selected factors whichcan predispose to coronary artery disease among South Indian population. JUSTIFICATION • To have efficient standardised focus on the study aim.

  27. change in sentence orientation and a word add up to ii, iii, iv and vthobjectives of the studydetails of amendments ii. To find if gender differences exist among normal coronary artery measurements. iii. To find the possible association of body mass index with normal vessel dimensions. iv. To find the distribution of diseased and non-diseased coronary arteries among normal and bridged coronary arteries. v.To find an association between cardiac dominance and coronary artery stenosis among each pattern of dominance. JUSTIFICATION • To have clear and correct focus on study objectives.

  28. AN ADD UP TO THE EXCLUSION CRITERIA details of amendment EXCLUSION CRITERIA: • If the patient is diabetic for five or more than five years regardless even after having normal coronaries will not be included for coronary artery measurement analysis. JUSTIFICATION • The literature implicates significant narrowing of coronary artery dimensions among diabetic patients after a period of five or more years.

  29. A CHANGE IN STUDY SETTINGdetails of amendments • A change in centre for data collection has been made. The centre is changed from Amrita School of Medicine , Ponnekkara, Kochi, Kerala; one of the pre-selected hospital in Kerala state to either Pariyaram Medical College, Kannur or Lisie hospital, Kochi, Kerala JUSTIFICATION • A letter has been received from the director (Copy enclosed with 1st progress report), Amrita School of Medicine, Ponnekkara, Kochi, Kerala demanding to involve one of the cardiologist from the study setting hospital as a co-guide for the study than keeping as a mender or acknowledging the hospital for data collection.

  30. Contd… • As it is a later stage to involve one more co-guide; the same was not acceptable for the candidate, guide and co-guide. • Due to this conflict of Interest ; the centre will be changed to either Pariyaram Medical College, Kannur or Lisie hospital, Kochi after procuring the study setting permission from the Registrar of Yenepoya university.

  31. A CHANGE IN FLOW CHART SHOWING PROCEDURES OF DATA COLLECTIONdetails of amendment JUSTIFICATION • Kindly excuse for the typing error while making flow chart

  32. Figure 3: Flow chart showing procedures of data collection

  33. Table 1: Categorisation of collected samples • Exc- Excluded; Inc- Included; NCCA-Non critical coronary artery; SVD-Single vessel disease; DVD-Double vessel disease; TVD-Triple vessel disease Table 2: Gender categorisation

  34. Table 3: Individual normal segment measurements of coronary artery with Mean±Standard deviation (STDEV) of total segments of each group LMCA- Left main coronary artery LAD(O,P)-Left anterior descending artery branch (Ostium,Proximal) DIAG-Diagonal branch LCx (O,P)-- Left circumflex branch of coronary artery branch (Ostium,Proximal) OM- Obtuse Marginal branch RCA(O,P)-- Right coronary artery branch (Ostium,Proximal)

  35. Table 4: Categorisation of gender among normal coronaries

  36. Table 5: Coronary artery measurement differences among male and female LMCA- Left main coronary artery LAD(O,P)-Left anterior descending artery branch (Ostium,Proximal) DIAG-Diagonal branch LCx (O,P)-- Left circumflex branch of coronary artery branch (Ostium,Proximal) OM- Obtuse Marginal branch RCA(O,P)-- Right coronary artery branch (Ostium,Proximal)

  37. Table 6: Correlation of BMI with coronary artery measurement Correlation is significant at the 0.05 level (2-tailed). Hence there is no correlation.

  38. Table 7: Distribution of bridged samples among coronary artery • LAD-Left anterior descending artery branch • DIAG-Diagonal branch • LCx- Left circumflex branch of coronary artery branch • OM- Obtuse Marginal branch • RCA- Right coronary artery branch

  39. Table 8: Categorisation of bridged segments • NCCA-Non critical coronary artery, • SVD-Single vessel disease, • DVD-Double vessel disease, • TVD-Triple vessel disease.

  40. Table 9: Bridged segment measurements

  41. Table 10: Cardiac dominance pattern and distribution of diseased segments among each pattern in percentages

  42. PhD WORK SUMMARY • Acceptance of Ph.D work proposal synopsis • Secured ethical clearance for the Ph.D study titled above from Yenepoya University Institutional Ethics Committee on 1st October 2016. • Secured NITTE University permission letter and ethical clearance on 12th November 2016. • Started data collection from K.S Hegde Medical Academy, Deralakatte, Mangalore, Karnataka.  • Scheduled presentation for ethical clearance from Madras Medical Mission on 17th December 2016.

  43. CONFERENCES ATTENDED WITH DETAILS OF PAPER PRESENTATION • Attended and presented research paper titled ‘Myocardial bridging ‘a double-edged sword’: Analysis and Significance’ in 64TH Annual National Conference of Anatomical Society (NATCON) of India held in AIIMS-JODHPUR- from 29th November – 1st December,2016 • Participated in the “CATHLAB CONCLAVE” organised by National Society of Cardiovascular Technologists, at Goa on 19th and 20th August, 2016 • Attended and presented research paper titled ‘Anomalous Origins And Branching Patterns In Coronary Arteries-An Angiographic Prevalence Study’ in 63RD Annual National Conference of Anatomical Society (NATCON) of India held at King George’s Medical College, Lucknow - from 20th November- 23rd November 2015

  44. PUBLICATIONS ACCEPTED/ COMMUNICATED/ MANUSCRIPTS READY FOR SUBMISSION: • PhD work proposal related Paul AD, Avadhani R, Subramanyam K. Anomalous origins and branching patterns in coronary arteries–An angiographic prevalence study. JASI.2016;65(2):136-142 Journal of the Anatomical Society of India (JASI) Journal Metrics • Impact Factor: 0.146 ℹ • 5-Year Impact Factor: 0.163 ℹ • Source Normalized Impact per Paper (SNIP): 0.139 ℹ • SCImago Journal Rank (SJR): 0.134 ℹ

  45. ACADEMIC PROGRESS • Successfully completed by clearing the University exam of PGDBEME Programme conducted by department of Forensic Medicine, YenepoyaUniversity, Deralakatte, Mangalore – 2016 January batch. • Secured ethical clearance and conducted study for the multi centre study of project proposal for PGDBEME Programme, titled “Evaluation of the effectiveness in perception and execution of ethical role responsibilities relevant to nursing practice among teaching staffs of nursing disciplinary” • Cleared with Elite grade (73%) for the online course on ‘Health Research Fundamentals’ by 'NIE-ICMR – [NieCer] e- certificate courses’ conducted by National Institute of Epidemiolory [NIEI] one of the premier institutes of Indian Council of Medical Research ICMR (NleGer) in collaboration with National programme on Technology Enhanced Learning (NPTEL).

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