RAPID-POP a Randomized Controlled Trial

NCT06430892 | Recruiting DMC

• 1 other identifier: IRB-23/2024
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy of the Pressure Optimization Protocol (POP) versus Conventional Stent Deployment Strategy during Primary PCI: An Open Label Randomized Clinical Trial The investigators will compare conventional rapid stent inflation/deflation during primary PCI with higher pressure and prolonged duration of stent deployment Study Hypothesis: The POP in stent deployment is superior to the conventional stent deployment approach with a significantly higher achievement of the TIMI III flow, significantly lesser occurrence of slow flow/no-reflow, and significantly higher rate of ST-Segment resolution during primary PCI.

Conditions

Myocardial Infarction, Acute

Outcome Measures

Primary Outcomes (3)

• TIMI III flow: TIMI III flow is defined as normal flow with complete filling of the distal vascular bed.

  To assess flow in the vessel after deployment of stent

  periprocedurally (after stent deployment)

• Slow-flow/no-reflow

  To assess is there any Slow-flow/no-reflow phenomenon , which is TIMI flow grade \< 3 and as myocardial blushing grade (MBG) \< 2.

  periprocedurally (after stent deployment)

• ST-segment resolution

  Assessment of ST-segment resolution , The electrocardiographic resolution of the ST-segment elevation is defined as a reduction of \> 50% of the ST-segment elevation in the same lead within 60 min after the index procedure

  Time frame:60minutes after the procedure

Secondary Outcomes (5)

• Cardiovascular death ( CV death)

  Time frame: during hospitalization (in-hospital)

• Myocardial infarction

  Time frame: during hospitalization (in-hospital)

• Stent thrombosis

  Time frame: during hospitalization (in-hospital)

• Cerebrovascular accident ( CVA /Stroke)

  Time frame: during hospitalization (in-hospital)

• Arrhythmias

  Time frame: during hospitalization (in-hospital)

Study Arms (2)

POP Protocol

OTHER

Patients in this arm will be treated according to the POP protocol for stent deployment

Procedure: Primary Percutaneous Coronary Intervention (PPCI)

Conventional method

OTHER

Patients in this arm will be treated with conventional method (rapid inflation-deflation protocol) for stent deployment

Procedure: Primary Percutaneous Coronary Intervention (PPCI)

Interventions

Primary Percutaneous Coronary Intervention (PPCI) PROCEDURE

Patients presented with acute myocardial infarction undergoing primary percutaneous coronary intervention with stent deployment

Conventional method; POP Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years and above.
• Patients undergoing primary percutaneous coronary intervention (PCI) with stent implantation.
• Presence of significant coronary artery stenosis (greater than 70% diameter reduction) confirmed by angiography.

You may not qualify if:

• Patients with Killip class IV
• Patients with significant comorbidities such as end-stage renal disease or advanced liver disease which may interfere with the procedure or follow-up.
• Prior history of coronary artery bypass grafting (CABG).
• Refusal to give consent for study participation or procedure

Sponsors & Collaborators

• National Institute of Cardiovascular Diseases, Pakistan: lead

Study Sites (1)

National institute of cardiovascular diseases

Karachi, Sindh, 75510, Pakistan

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• ABDUL HAKEEM, PROF

  National Institute of Cardiovascular Diseases, Pakistan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdul Hakeem, professor

CONTACT

+923355554342; abdulhakeem@gmail.com

Shakir Zada, fellow

CONTACT

+923469467449; dr.shakir637@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This will be an open-label study, however, the outcome assessment will be blinded. A de-identified CD and post-PCI ECG with a unique tracking ID will be evaluated by the team of independent consultants, who will be blinded to the stent placement approach, and primary outcome variables i.e. TIMI flow, slow-flow/no-reflow, and ST-segment resolution will be assessed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Participants will be randomized into two groups in 1:1 , one arm will be treated with POP protocol and the other arm will be treated with conventional method.

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 28, 2024
• Study Start: May 15, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)