In-hospital Versus After-discharge Complete Revascularization (REVIVA-ST)

April 21, 2023 updated by: Eva Rumiz González, Hospital General Universitario de Valencia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Alberto Berenguer Jofresa, MD, PhD

Study Locations

  • Spain
      • Valencia, Spain
        • Hospital General Universitario de Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Patients with STEMI whom undergo successful primary PCI of the culprit lesion, who have at least one non-culprit lesion suitable for treatment in a stage procedure.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: In-hospital complete revascularization group.
Patients will undergo to a complete revascularization of non-culprit lesions at least 24 hours after STEMI and before hospital discharge.
Other: In-hospital nonculprit-lesions percutaneous coronary intervention (PCI)
To perform percutaneous coronary intervention of non-culprit vessels in a staged procedure during index admission.
Other: After-discharge complete revascularization group.
Patients will undergo to a complete revascularization of non-culprit lesions after hospital discharge within 4-6 weeks after STEMI.
Other: After-discharge nonculprit-lesions percutaneous coronary intervention (PCI)
To perform percutaneous coronary intervention of non-culprit vessels in a staged procedure after hospital discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario de Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2018

Primary Completion (Actual)

November 25, 2021

Study Completion (Actual)

December 21, 2022

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

February 3, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGUValencia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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