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REperfusion Facilitated by LOcal Adjunctive Therapy in ST-elevation Myocardial Infarction

NCT01747174 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2015-06-16

No results posted yet for this study

Summary

The purpose of this study is to determine whether intra-coronary adenosine or sodium nitroprusside (SNP) delivered selectively via a thrombus aspiration catheter (or if unsuccessful via a coronary microcatheter) following thrombus aspiration in Primary Percutaneous Coronary Intervention (P-PCI) reduces microvascular obstruction (MVO) parameters and infarct size as measured with cardiac MRI, compared with standard treatment following thrombus aspiration in patients presenting with ST-elevation myocardial infarction (STEMI).

Conditions

  • ST-elevation Myocardial Infarction (STEMI)

Interventions

DRUG

IC Adenosine

IC Adenosine 1mg injected distally via micro-catheter in to IRA following thrombus aspiration with further dose (1mg if IRA is RCA otherwise 2mg) via guide catheter following coronary stent deployment.

DRUG

IC Sodium nitroprusside (SNP)

IC SNP 250mcg injected distally via micro-catheter distally in to IRA following thrombus aspiration with further 250 mcg dose delivered via guide catheter following coronary stent deployment.

PROCEDURE

Standard PCI

PCI procedure with thrombectomy (via aspiration catheter) and bivalirudin given as standard.

Sponsors & Collaborators

  • University Hospitals, Leicester

    lead OTHER

Principal Investigators

  • Anthony H Gershlick, MBBS, FRCP · University of Leicester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01747174 on ClinicalTrials.gov