A trial to study the role of vascular bed preparation in patients with primary PCI.

Phase 2

Not yet recruiting

Conditions: Atherosclerosis of other arteries,

Registration Number: CTRI/2023/08/056317

Lead Sponsor: VMMC and Safdurjung Hospital

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 135

Inclusion Criteria

Patients with STEMI (undergoing primary PCI) as per the Fourth Universal Definition of Myocardial Infarction Criteria will be recruited.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	At baseline and 30 day
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	At baseline and 30 day
3 To compare proximal & distal delivery of vasodilators in patients undergoing routine vascular bed preparation	At baseline and 30 day

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): VMMC AND SAFDURJUNG HOSPITAL
🇮🇳
South, DELHI, India
VMMC AND SAFDURJUNG HOSPITAL
🇮🇳South, DELHI, India
Dr Saurabh Kumae Singh
Principal investigator
7903935414
saurabh120994@gmail.com