| CTRI Number |
CTRI/2019/02/017520 [Registered on: 07/02/2019] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
To look at the safety of heart blood vessels treatment with clot aspiration and saline injection in heart attack patients compared to methods that are commonly used in medical practice. |
|
Scientific Title of Study
|
The Role of Undersized Balloon Pre-Dilation Before Thrombus Aspiration and Saline Auto-Perfusion On Tissue Reperfusion in Patients With ST-Elevation Myocardial Infraction – A Prospective Cohort Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rekha V |
| Designation |
Assistant Professor |
| Affiliation |
School of Allied Health Sciences, MAHE |
| Address |
Room No 212, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal
Department of Cardiology, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9663682484 |
| Fax |
|
| Email |
rekhashree16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rekha V |
| Designation |
Assistant Professor |
| Affiliation |
School of Allied Health Sciences, MAHE |
| Address |
Room No 212, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal
Department of Cardiology, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9663682484 |
| Fax |
|
| Email |
rekhashree16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rekha V |
| Designation |
Assistant Professor |
| Affiliation |
School of Allied Health Sciences, MAHE |
| Address |
Room No 212, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal
Department of Cardiology, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9663682484 |
| Fax |
|
| Email |
rekhashree16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of cardiology, kasturba hospital, manipal |
|
|
Primary Sponsor
|
| Name |
Rekha V |
| Address |
Room no 212, 2nd floor, SOAHS, MAHE, Manipal |
| 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 |
| Rekha V |
Kasturba Hospital |
Cardiac Catheterization Laboratory
Department of Cardiology
KMC, Manipal
Udupi
KARNATAKA |
9663682484
rekhashree16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I212||ST elevation (STEMI) myocardial infarction of other sites, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
treatment includes small balloon pre dilatation, thrombus aspiration and saline infusion |
the treatment groups are as follows:
1. pre dilatation followed by thrombus aspiration and saline infusion.
2. pre dilatation followed by thrombus aspiration, but no saline infusion.
3. with no pre dilatation but thrombus aspiration and saline infusion will be done.
4. no pre dilatation and no saline infusion but thrombus aspiration will be done |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
patients presenting with heart attack |
|
| ExclusionCriteria |
| Details |
previous thrombolytic therapy, post CABG |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| use of small sized balloon pre dilatation before clot aspiration and saline injection may reduce the vessel occlusion and improve the blood circutaion |
Assessement will be done immediate after the coronary angioplasty |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| use of saline injection after improving blood flow in the diseased vessel may reduce slow flow of the blood |
4 years |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "385"
Final Enrollment numbers achieved (India)="385" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2019 |
| Date of Study Completion (India) |
25/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is single centre prospective cohort study, patients presenting with Myocardial infarction will be taken for primary intervention as an emergency treatment. |