| CTRI Number |
CTRI/2023/08/056317 [Registered on: 09/08/2023] Trial Registered Prospectively |
| Last Modified On: |
08/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A trial to study the role of vascular bed preparation in patients with primary PCI. |
|
Scientific Title of Study
|
Comparison of routine vascular bed preparation versus need based vascular bed preparation in patients undergoing primary PCI |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
saurabh kumar singh |
| Designation |
senior resident |
| Affiliation |
Vardhman Mahavir Medical College (VMMC ) & Safdarjung Hospital |
| Address |
PR-7, Flat-5, 4th floor , Rai Saheb Estate, near Laxmi Narayan Mandir, masjid modh, south extension-II, Delhi
South
DELHI
110049
India |
| Phone |
7903935414 |
| Fax |
|
| Email |
saurabh120994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
sandeep bansal |
| Designation |
Professor and head department of cardiology |
| Affiliation |
Vardhman Mahavir Medical College (VMMC) and Safdurjung hospital |
| Address |
Department of cardiology, Vardhman Mahavir Medical College (VMMC) AND Safdarjung hospital, Room no-754, 7th floor, Super-speciality building (SSB)
South
DELHI
110049
India |
| Phone |
9810543368 |
| Fax |
|
| Email |
drsbansal2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
sandeep bansal |
| Designation |
Professor and head department of cardiology |
| Affiliation |
Vardhman Mahavir Medical College (VMMC) AND Safdurjung hospital |
| Address |
room 754,7th floor ,Superspeciality building (SSB), department of cardiology Vardhman Mahavir Medical college (VMMC)AND Safdurjung hospital
South
DELHI
110049
India |
| Phone |
9810543368 |
| Fax |
|
| Email |
drsbansal2000@yahoo.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdurjung Hospital |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdurjung Hospital |
| Address |
VMMC and Safdurjung Hospital, near AIIMS, Ansari nagar, New Delhi 110029 |
| 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 Saurabh Kumae Singh |
VMMC AND SAFDURJUNG HOSPITAL |
Department of Cardiology, SSB building, 7th floor
South
DELHI |
7903935414
saurabh120994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Vardhman Mahavir Medical College (VMMC) & Safdarjung Hospital, New Delhi-110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: I708||Atherosclerosis of other arteries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Vascular bed preparation (intracoronary vasodilation)prior to primary PCI |
Total duration of our study will be 18 month. Our study will include 135 patients with STEMI undergoing primary PCI (90 patients with vascular bed preparation prior to primary PCI and 45 patients with routine primary PCI without vascular bed preparation) after fulfilling inclusion and exclusion criteria. Intracoronary vasodilator via guiding catheter followed by primary PCI and Targeted intracoronary delivery of vasodilator followed by primary PCI |
| Comparator Agent |
Routine primary PCI |
Total duration of our study will be 18 month. Routine Primary PCI without any vascular bed preparation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with STEMI (undergoing primary PCI) as per the Fourth Universal Definition of Myocardial Infarction Criteria will be recruited. |
|
| ExclusionCriteria |
| Details |
1) Presence of cardiogenic shock (Killip class IV)
2) Severe hypertension (BP> 180/110 mmHg) without control
3) Severe multiple organ failure
4) A recent history of CABG
5) A clinical diagnosis of aortic dissection |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To compare the efficacy in terms of TIMI flow grade, TIMI frame count, TMP grade of routine vascular bed preparation versus need based vascular bed preparation in patients undergoing primary PCI
2 To compare the in hospital & 30-day MACEs (major adverse cardiac events) in patients undergoing primary PCI in routine vascular bed preparation versus need based vascular bed preparation
3 To compare proximal & distal delivery of vasodilators in patients undergoing routine vascular bed preparation |
At baseline and 30 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To compare the in hospital & 30-day MACEs (major adverse cardiac events) in patients undergoing primary percutaneous coronary intervention in routine vascular bed preparation versus need based vascular bed preparation
2 To compare proximal & distal delivery of vasodilators in patients undergoing routine vascular bed preparation |
Inhospital & 30 day MACE after primary PCI |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/09/2023 |
| 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="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
|
Primary percutaneous coronary intervention (PCI) is one of the most effective treatments for acute ST-segment elevation myocardial infarction (STEMI). However, despite the presence of normal epicardial flow, post-procedural microvascular obstruction (MVO) which substantially reduces the beneficial effects of PCI, remains an important limitation of the procedure.Since presence of no-reflow is related to higher risk of major adverse cardiac events (MACE) due to the poor healing of the infarct, adverse left ventricular remodeling, congestive heart failure occurrence and death. There is paucity of data with respect to vascular bed preparation prior to primary PCI in patients with STEMI. Currently, there is still a lack of an optimal treatment for no-reflow phenomenon. Prevention can be effective to reduce no-reflow occurrence with medical therapy. Hence, various strategies to prevent no reflow like vascular bed preparation prior to primary PCI can be beneficial, as our aim of revascularization is to improve coronary blood flow at the level of microcirculation to reduce myocardial damage and improve clinical outcome. Various centers are practicing vascular bed preparation prior to primary PCI, in our hospital also both (intracoronary vasodilator via guiding catheter followed by primary PCI and targeted intracoronary delivery of vasodilator followed by primary PCI) methods of vascular bed preparation is being practiced. There is no standard guideline at present for the various methods of intracoronary therapies prior to primary PCI. Therefore, this study is designed with the aim of role of various methods of vascular bed preparation prior to primary PCI. |