| CTRI Number |
CTRI/2020/02/023209 [Registered on: 10/02/2020] Trial Registered Retrospectively |
| Last Modified On: |
07/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the clinical presentation, risk factors and outcomes of patients admitted with chest pain in general medical wards in our hospital. |
|
Scientific Title of Study
|
To study the Clinical characteristics, RIsk factors, long term Morbidity & Mortality of patients with Acute Coronary Syndrome admitted in general medical wards ( CRIMM ACS study ) |
| Trial Acronym |
CRIMM ACS study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jaifrin Daniel |
| Designation |
PG registrar |
| Affiliation |
Christian Medical College. Vellore |
| Address |
Department of Medicine- Unit 2
Christian Medical College Hospital
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9789230877 |
| Fax |
|
| Email |
jdaniel.m07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Thambu David Sudarsanam |
| Designation |
Professor and Head |
| Affiliation |
Christian Medical College. Vellore |
| Address |
Department of Medicine- Unit 2
Christian Medical College Hospital
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9486660653 |
| Fax |
|
| Email |
thambu@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaifrin Daniel |
| Designation |
PG registrar |
| Affiliation |
Christian Medical College. Vellore |
| Address |
Department of Medicine- Unit 2
Christian Medical College Hospital
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9789230877 |
| Fax |
|
| Email |
jdaniel.m07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian Medical College Vellore, Fluid Research Grant |
|
|
Primary Sponsor
|
| Name |
Christian Medical College Vellore |
| Address |
Christian Medical College Hospital
Vellore
Tamilnadu
632004 |
| Type of Sponsor |
Private medical college |
|
|
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 Jaifrin Daniel |
Christian Medical College Vellore |
Department of Medicine
OPD Buildding,
2nd floor
Vellore
TAMIL NADU |
9789230877
jdaniel.m07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All proven patients of Acute Coronary Syndrome based clinical findings, ECG changes and elevated cardiac troponins admitted in general medical wards |
|
| ExclusionCriteria |
| Details |
Patients admitted in Coronary care units |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine mortality - in hospital, one month and six months of patients with Acute Coronary Syndrome.
2. To determine morbidity - in hospital, one month and six months of patients with Acute Coronary Syndrome |
At hospitalisation, One month and 6 months of discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) To study the risk factors predisposing to Acute Coronary Syndrome
b) To assess the association between socioeconomic strata and mortality from acute coronary syndromes.
c) To assess the predictors of 6 month mortality among these patients
|
March 2016 to February 2017 |
|
|
Target Sample Size
|
Total Sample Size="149"
Sample Size from India="149"
Final Enrollment numbers achieved (Total)= "149"
Final Enrollment numbers achieved (India)="149" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2016 |
| Date of Study Completion (India) |
31/07/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Acute coronary syndrome is an important cardiovascular illness which is in a rise due to various risk factors and lifestyle changes. NSTEMI, STEMI and UA constitute ACS. There is a rise in patients admitted in general medical wards with NSTEMI as compared to STEMI in our hospital. It is important to understand the clinical presentation, risk factors and lifestyle associated predisposing to it. There is a paucity of data on morbidity and mortality – in hospital and long term, in proven cases of STEMI and NSTEMI admitted to general medical wards in our institution. On studying the clinical presentation and identifying the predisposing factors will help in better understanding of the disease, early recognition which would translate to better outcomes and prevention of further cardiovascular events in the future. The risk of death or recurrent Myocardial infarction at admission will be calculated using the TIMI score/GRACE and compared with our data of morbidity and mortality. We will also see whether there is any variation of outcome among patients with different economic strata. |