| CTRI Number |
CTRI/2021/07/034862 [Registered on: 15/07/2021] Trial Registered Prospectively |
| Last Modified On: |
29/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Profile of Myocardial Infarction |
|
Scientific Title of Study
|
Clinical And Angiographic Profile Of Acute Myocardial Infarction In Young Adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aineesh Vallurupalli |
| Designation |
Junior Resident |
| Affiliation |
Kasturba hospital manipal |
| Address |
room no 18 2nd floor general medicine department opd block Kasturba hospital manipal
Udupi KARNATAKA 576104 India |
| Phone |
9663974497 |
| Fax |
|
| Email |
aineeshv@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vasudeva Acharya |
| Designation |
Professor |
| Affiliation |
kasturba hospital manipal |
| Address |
room no 19 2nd floor general medicine department opd block Kasturba hospital manipal
Udupi KARNATAKA 576104 India |
| Phone |
8197597008 |
| Fax |
|
| Email |
acharya.vasudev@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Aineesh Vallurupalli |
| Designation |
Junior Resident |
| Affiliation |
kasturba hospital manipal |
| Address |
room no 18 2nd floor general medicine department opd block Kasturba hospital manipal
Udupi KARNATAKA 576104 India |
| Phone |
9663974497 |
| Fax |
|
| Email |
aineeshv@gmail.com |
|
|
Source of Monetary or Material Support
|
| kasturba hospital manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba hospital manipal university |
| Address |
KMC Manipal Tiger Circle Road Madhav Nagar Manipal Karnataka 576104 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vasudeva Acharya |
Kasturba hospital manipal |
room no 19 2nd floor general medicine department opd block Kasturba hospital manipal Tiger Circle Road, Madhav Nagar Manipal Karnataka 576104 Udupi KARNATAKA |
8197597008
acharya.vasudev@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patient aged greater than 18 years of age or less than 45 years of age
Patients admitted to kasturba medical college and hospital manipal with a diagnosis of acute Myocardial infarction based on the WHO Criteria
|
|
| ExclusionCriteria |
| Details |
Patients with age less than 18 years or greater than 45 years of age
Patient with a history of prior myocardial infarction or revascularisation
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
To study clinical profile of Myocardial infarction in Young adults
To study etiological profile, angiographical profile and the outcome of myocardial infarction in the above population
|
To study clinical profile of Myocardial infarction in Young adults
To study etiological profile, angiographical profile and the outcome of myocardial infarction in the above population over 18 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study outcome of Myocardial infarction in Young adults
|
Patients will be included in the study as per inclusion and exclusion criteria after written and informed consent. Detailed clinical history and examination findings will be entered in predesigned proforma. As per standard protocol the patients will undergo ECG, Echocardiography laboratory investigations and angiography by the treating doctor and the data will be noted. The patient’s in-hospital course and outcome will be assessed
Patints will be assed during there course in the hospital |
|
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Target Sample Size
|
Total Sample Size="144" Sample Size from India="144"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/07/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="1" Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Previous studies have reported that there is a rising incidence of ACS in the young. The currently available evidence suggests young patients represent 0.4-19% of all ACS cases[4] · A significant proportion of the burden of coronary heart disease is attributed to behavioral or lifestyle factors including poor diet, obesity, and tobacco use. · Biomedical risk factors such as hypercholesterolemia, hypertension, obesity, and diabetes are also known to contribute to the development of the disease. [5] · In an analysis of age-standardized coronary heart disease (CHD) mortality in Canada over a 15-year period, South Asians had the highest CHD mortality compared with individuals of Chinese and European descent. [6] · South Asians where found to be prone to developing CHD at a younger age, often before the age of 45 years in men and are more likely to have significant left main, multi-vessel, and distal coronary artery disease.[6] · Consequences of MI can be devastating particularly at a young age due to its greater potential impact on the patient’s psychology, ability to work and the socioeconomic burden. As ‘‘young’’ MI patients may be the main income producer of the family, the aftermath of MI can also affect multiple dependents. literature focussing on premature myocardial infarction (MI) in the young and focusing on the Indian population is lacking. Hence, it is important to identify the major risk factors and clinical profile of ACS in young adults so that future preventive measures can be taken in the form of lifestyle modification and pharmacotherapy |