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OpenTrials
Completed

NCT Number: NCT04743154

In-hospital Versus After-discharge Complete Revascularization

Patients with STEMI and multivessel disease in whom the culprit lesion has been successfully revascularized during prmimary PCI, will be randomized to in-hospital or after-discharge complete revascularization.

The purpose of this study is to evaluate the impact of these two different strategies in terms of hospital stay.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General Universitario de Valencia

Valencia, Spain

About this study

STEMI patients with mutivessel disease are, after successful primary angioplasty, randomized 1:1 ratio to either in-hospital complete revascularization or after-discharge complete revascularization strategy.

Eligible non-culprit coronary arteries must be >2.0 mm in diameter and at the discretion of the operator suitable for PCI. Only arteries with angiographically stenoses ≥70% or between ≥50% and <70 in proximal segments can be randomized.

Patients in the in-hospital revascularization group will undergo to non-culprit percutaneous coronary intervention (PCI) at least 24 hours after ST-segment elevation myocardial infarction. On the other hand, patients in the after-discharge group will undergo to non-culprit PCI within 4-6 weeks after STEMI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute onset of chest pain <12 hours duration.
  • ST-segment elevation ≥ 0.1 millivolt in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block.
  • Culprit lesion in a major native vessel, with successful primary PCI.
  • Presence of at least one non-culprit lesion more than or equal to 70% of stenosis in a vessel more than 2mm of diameter or more than or equal to 50% stenosis in proximal segments.
  • The patient is able to give written consent for participation in the study.

Exclusion criteria

  • Pregnancy.
  • Significant left main stenosis.
  • Stent thrombosis.
  • Chronic total occlusion.
  • Severe stenosis of non-culprit vessels with distal flow less than TIMI3.
  • Significant non-culprit stenosis no candidate to revascularization.
  • Presence of valvulopathy candidate for cardiac surgery.
  • Cardiogenic shock status at admission.
  • The patient is not able to give written consent for participation in the study.

Treatment and study plan

In-hospital nonculprit-lesions percutaneous coronary intervention (PCI)

Other

To perform percutaneous coronary intervention of non-culprit vessels in a staged procedure during index admission.

After-discharge nonculprit-lesions percutaneous coronary intervention (PCI)

Other

To perform percutaneous coronary intervention of non-culprit vessels in a staged procedure after hospital discharge.

Primary outcomes

  1. Impact in hospital stay

    Time frame: 6 months

    To evaluate the impact of two different revascularization strategies (in-hospital versus after-discharge) in terms of hospital stay (days) in patients with a STEMI and multivessel disease.

Secondary outcomes

  1. Cardiovascular death, acute myocardial infarction or revascularization.

    Time frame: 1 year

    Composite of cardiovascular death, myocardial infarction, or ischemia driven revascularization of non-culprit coronary lesions eligible for and randomized to either of the two strategies.

  2. Fractional flow reserve of angiographically moderate stenosis

    Time frame: 6 months

    Evaluate the presence of ischemia by analyzing the fractional flow reserve of angiographically moderate stenoses (≥50% and <70) in proximal segments of the anterior descending, circumflex, or right coronary artery.

Sponsors and collaborators

Lead sponsor

Hospital General Universitario de Valencia

Other

Registry information

Official study title

In-hospital Versus After-discharge Complete Revascularization in STEMI Patients With Multivessel Disease.

Acronym: REVIVA-ST

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Feb 8, 2021
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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