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

Primary Purpose

STEMI - ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional other trial for STEMI - ST Elevation Myocardial Infarction focused on measuring STEMI, Multivessel, PCI

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital General Universitario de Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

In-hospital complete revascularization group.

After-discharge complete revascularization group.

Arm Description

Patients will undergo to a complete revascularization of non-culprit lesions at least 24 hours after STEMI and before hospital discharge.

Patients will undergo to a complete revascularization of non-culprit lesions after hospital discharge within 4-6 weeks after STEMI.

Outcomes

Primary Outcome Measures

Impact in hospital stay

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 Outcome Measures

Cardiovascular death, acute myocardial infarction or revascularization.

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.

Fractional flow reserve of angiographically moderate stenosis

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.

Full Information

NCT ID

NCT04743154

First Posted

February 3, 2021

Last Updated

April 21, 2023

Sponsor

Hospital General Universitario de Valencia

1. Study Identification

Unique Protocol Identification Number

NCT04743154

Brief Title

In-hospital Versus After-discharge Complete Revascularization

Acronym

REVIVA-ST

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

January 20, 2018 (Actual)

Primary Completion Date

November 25, 2021 (Actual)

Study Completion Date

December 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital General Universitario de Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

STEMI - ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease

Keywords

STEMI, Multivessel, PCI

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Actual)

8. Arms, Groups, and Interventions

Arm Title

In-hospital complete revascularization group.

Arm Type

Other

Arm Description

Patients will undergo to a complete revascularization of non-culprit lesions at least 24 hours after STEMI and before hospital discharge.

Arm Title

After-discharge complete revascularization group.

Arm Type

Other

Arm Description

Patients will undergo to a complete revascularization of non-culprit lesions after hospital discharge within 4-6 weeks after STEMI.

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Impact in hospital stay

Description

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.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Cardiovascular death, acute myocardial infarction or revascularization.

Description

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.

Time Frame

1 year

Title

Fractional flow reserve of angiographically moderate stenosis

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eva Rumiz Gonzalez, MD, PhD

Organizational Affiliation

Hospital General Universitario de Valencia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital General Universitario de Valencia

City

Valencia

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

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