| CTRI Number |
CTRI/2024/01/061723 [Registered on: 22/01/2024] Trial Registered Prospectively |
| Last Modified On: |
21/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Occurrence and predictors of irregular heart rhythms and sudden cardiac death in the first 48hours after a heart attack |
|
Scientific Title of Study
|
Clinical profile of arrhythmias post acute myocardial infarction in the first 48hours |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sreeja Gandamsetty |
| Designation |
Junior Resident, Department of Medicine |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Medical College Tiger Circle Road, Madhav Nagar, Manipal,
Udupi KARNATAKA 576104
India.
Udupi KARNATAKA 576104 India |
| Phone |
7382009444 |
| Fax |
|
| Email |
sreejagandhamsetty863@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ananthakrishna Shastry |
| Designation |
Professor and Head of unit, Medicine 13 |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Medical College Tiger Circle Road, Madhav Nagar, Manipal,
Udupi KARNATAKA 576104
Udupi KARNATAKA 576104 India |
| Phone |
9845702450 |
| Fax |
|
| Email |
ba.shastry@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr T S Shashikala |
| Designation |
Assistant Professor, Department of General Medicine |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Medical College Tiger Circle Road, Madhav Nagar, Manipal,
Udupi KARNATAKA 576104
Udupi KARNATAKA 576104 India |
| Phone |
9441383024 |
| Fax |
|
| Email |
shashikala.ts@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
Dr Sreeja Gandamsetty |
| Address |
Department of Medicine, Kasturba Medical College , Manipal, Udupi, Karnataka, 576104 |
| Type of Sponsor |
Other [self] |
|
|
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 Sreeja Gandamsetty |
Kasturba Medical College, Manipal |
Department of Medicine, Kasturba medical college, Manipal, Udupi, Karnataka, India. 576104 Udupi KARNATAKA |
7382009444
sreejagandhamsetty863@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital I Institutional Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I21||Acute myocardial infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with acute myocardial infarction above 18 years of age who can give written informed consent.
Acute myocardial infarction (MI) : Acute myocardial injury with clinical evidence of acute myocardial
ischemia and with detection of a rise and,or fall of cT values with at least one value above the 99th
percentile URL and at least one of the following:
1)Symptoms of myocardial ischemia
2)New ischemic electrocardiographic (ECG) changes
3) Development of pathologic Q waves
4)Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a
pattern consistent with an ischemic etiology |
|
| ExclusionCriteria |
| Details |
1)Pregnant females
2)History of prior myocardial infarction or chronic heart failure
3)Patients already on anti arrhythmics or drugs prolonging QT interval
4)Patients with previously diagnosed structural and valvular heart diseases- cardiomyopathy, congenital heart
5)Patients with previously diagnosed channelopathies or conduction disorders
6)Patient on cardiac device therapy
7)Prior documented cardiac conduction abnormalities
8)Documented Active infection
9)Autoimmune diseases
10)Malignancy
11)Chronic obstructive pulmonary disease
12)Hypothyroidism
13)Hyperthyroidism
14)Documented Anemia
15)Patients on Beta blockers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between acute myocardial Infarction and arrhythmias in the first 48hours. |
At the time of recruitment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyze risk factors associated with increased occurrence of arrhythmias post acute MI
Evaluation of ECG indices associated with arrhythmias post acute MI in the first 48hours |
At the time of recruitment. |
|
|
Target Sample Size
|
Total Sample Size="196" Sample Size from India="196"
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)
|
31/01/2024 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Arrhythmias, may occur at any time of myocardial infarction, beginning from the early minutes of acute infarction till the remote post-MI period.Although the incidence of VAs has declined in the hospital phase of acute coronary syndromes (ACS) mainly due to prompt revascularization and early introduction of optimal medical therapy, the risk of cardiac arrest and sudden cardiac death (SCD) remains increased after MI and are predictors of worse in-hospital outcome in the setting of ACS. Need for the study: Risk factors if identified, helps in risk stratification, primary prevention and early intervention thereby reducing the morbidity and mortality associated with arrhythmias, which are a major cause of death in the early (<48hrs) post acute myocardial infarction period. Description: A total of 196 participants will be recruited in the study after written informed consent ,using a preformed proforma, clinical, laboratory and imaging parameters will be collected from patients’ fitting the inclusion criteria. The parameters will be noted and relevant statistical analysis will be done to find correlation between acute myocardial Infarction and arrhythmias. The study will go on for 18months. Detailed description of procedure / processes: After written informed consent ,using a preformed proforma, clinical, laboratory and imaging parameters will be collected from patients’ fitting the inclusion criteria. 1.Categorical variables will be expressed as frequency/percentage and will be compared using chiâ€square test. 2.Continuous variables with normal distribution will be presented as mean ± standard deviation (SD)-compared using unpaired t test. Nonâ€normally distributed data will be expressed as median and interquartile range (IQR)-compared using Mann Whitney U test. 3.Multivariate logistic regression analysis will be performed to identify independent risk factors. A pâ€value < 0.05 will be considered statistically significant for all tests.
|