| CTRI Number |
CTRI/2023/09/057902 [Registered on: 21/09/2023] Trial Registered Prospectively |
| Last Modified On: |
20/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To find the relation between various blood parameters and functioning of heart in ST elevation myocardial infarction patients. |
|
Scientific Title of Study
|
Correlation of left ventricular ejection fraction with cardiac troponin I and serum ferritin levels in acute ST elevation myocardial infarction patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lovish Batheja |
| Designation |
Internal Medicine Resident |
| Affiliation |
GGSMCH, FARIDKOT. |
| Address |
Department of Medicine.
Guru Gobind Singh Medical College and Hospital, Faridkot.
Faridkot
PUNJAB
151203
India |
| Phone |
7777800027 |
| Fax |
|
| Email |
lovishbatheja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sumit Kumar |
| Designation |
Associate Professor |
| Affiliation |
GGSMCH, FARIDKOT |
| Address |
Department of Medicine
Guru Gobind Singh Medical College and Hospital,Faridkot.
Faridkot
PUNJAB
151203
India |
| Phone |
9876170157 |
| Fax |
|
| Email |
dr.sumitkumar1984@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sumit Kumar |
| Designation |
Associate Professor |
| Affiliation |
GGSMCH, FARIDKOT |
| Address |
Department of Medicine
Guru Gobind Singh Medical College and Hospital.
Faridkot
PUNJAB
151203
India |
| Phone |
9876170157 |
| Fax |
|
| Email |
dr.sumitkumar1984@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Medicine, GGSMCH, Faridkot. |
|
|
Primary Sponsor
|
| Name |
GGSMCH FARIDKOT |
| Address |
Department of Medicine
Guru Gobind Singh Medical College and Hospital, Faridkot. |
| Type of Sponsor |
Government 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 Lovish Batheja |
Guru Gobind Singh Medical College and Hospital, Faridkot. |
Department of Medicine, Guru Gobind Singh Medical College and Hospital,Faridkot.
Faridkot
PUNJAB |
7777800027
lovishbatheja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Thesis and Ethics Committee,GGSMCH, Faridkot. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I213||ST elevation (STEMI) myocardial infarction of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Acute onset MI as diagnosed by typical clinical presentation.
2. ECG characteristics specific of STEMI. |
|
| ExclusionCriteria |
| Details |
1.Previous history of myocardial infarction.
2.A patient having pre existing ECG changes s/o old MI or ECG showing Q wave at the time of admission.
3. Any congenital or structural heart disease.
4. LVH, conduction defects, heart blocks.
5. Conditions in which Troponin I levels increases irrespective of heart disease.: renal impairment, rheumatoid arthritis, pericarditis, spesis, acute congestive heart failure, acute pulmonary embolism, or prolonged tachyarrythmias.
6. Hemochromatosis, liver disease, TB, patients on iron supplements. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Troponin I levels
S. ferritin levels
Left ventricular ejection fraction |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation OF S. ferritin & troponin I levels along with their correlation with left ventricular ejection fraction |
baseline |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
01/10/2023 |
| 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="0"
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
|
India has the highest burden of Acute Coronary Syndrome (ACS) patients in the world. Indian Patients who suffer from ACS are relatively younger and have a significantly higher proportion of ST-elevation myocardial infarction (STEMI) as compared to patients in developed countries. It is estimated that more than 3 million STEMI occurs every year in India. The measurement of left ventricular ejection fraction (LVEF) after acute myocardial infarction (AMI) is a class I clinical practice guideline recommendation, and has both prognostic and therapeutic implications. Reduced LVEF is associated with greater mortality in patients with coronary artery disease and predicts increased risks of early mortality, as well as sudden cardiac death. Serum ferritin is an acute phase reactant and is considered to be a risk factor for MI. High serum ferritin may increase the risk of MI in the presence of other risk factors that increase the formation of free radicals, thus accelerating atherogenesis through stimulation of low-density lipoprotein oxidation. So, the aim of the study is to find the correlation of troponin I and ferritin levels with left ventricular ejection fraction in ST elevation MI patients presenting to the hospital. |