| CTRI Number |
CTRI/2025/04/084292 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Probable cause for severe heart attack |
|
Scientific Title of Study
|
Predictors of multivessel coronary artery disease in all patients presenting with ST- segment elevation myocardial infraction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharath V D |
| Designation |
Post graduate student |
| Affiliation |
Department of Cardiology, Department of Cardiovascular Technology |
| Address |
Vollagerehalli village maddur taluk Mandya
98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017
Bangalore
KARNATAKA
571428
India |
| Phone |
7406067431 |
| Fax |
|
| Email |
sharathvd5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rekha v |
| Designation |
Assistant professor ( Selection grade ) |
| Affiliation |
Department of Cardiology, Department of Cardiovascular Technology |
| Address |
98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka
98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017
Bangalore
KARNATAKA
560017
India |
| Phone |
9663682484 |
| Fax |
|
| Email |
rekha.v@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sharath V D |
| Designation |
Post graduate student |
| Affiliation |
Department of Cardiology, Department of Cardiovascular Technology |
| Address |
Vollagerehalli village, maddur taluk, Mandya
98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017
Bangalore
KARNATAKA
571428
India |
| Phone |
7406067431 |
| Fax |
|
| Email |
sharathvd5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal hospital bangalore |
|
|
Primary Sponsor
|
| Name |
Self Sponsored |
| Address |
Vollagerehalli village maddur taluk Mandya |
| Type of Sponsor |
Other [Self Sponsored ] |
|
|
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 |
| Ms REKHA V |
Manipal Hospital Bangalore |
Department of Cardiology, Department of Cardiovascular Technology,
Bangalore
KARNATAKA |
9663682484
rekha.v@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal Hospital Bangalore |
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 |
Nill |
Nill |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.All consecutive patients diagnosed with STEMI defined by the European Society of
Cardiology (ESC) / American College of Cardiology Foundation will be included in
the study.
2. All STEMI patients with age 18 years and above will be included in the study with
irrespective of gender. |
|
| ExclusionCriteria |
| Details |
1. Following Patients will be excluded from analysis if the final diagnosis is not an acute
myocardial infarction like patients with myopericarditis, Takotsubo syndrome,
coronary spasm, old myocardial infarction, massive pulmonary embolism, electrolyte
abnormality.
2. Patients presenting with STEMI on ECG due to IN-Stent Restenosis (ISR).
3. patients with previous history of coronary artery diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate detailed clinical, demographical and Laboratory profile in all patients
presenting with ST segment elevation myocardial infarction. |
6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| severity of coronary artery disease by SYNTEX scoring method with respect to risk factors. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
30/04/2025 |
| 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
|
The purpose of this study is to evaluate the predictors of risk factors for multivessel coronary artery disease, specifically focusing on identifying the factors most likely to cause MVD in patients with STEMI. • The purpose of this study is to assess the severity of coronary artery disease in relation to underlying risk factors that are likely to contribute to the development of multivessel coronary artery disease in the context of ST segment elevation myocardial infarction. |