NCT05949515

Brief Summary

The purpose of this multicenter study is to assess the impact of SSO2 treatment on clinical outcomes and left ventricular function in patients following acute ST-segment elevation myocardial infarction (STEMI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
403

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

July 31, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

June 28, 2023

Last Update Submit

April 3, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change of Left Ventricular Ejection Fraction

    Between group comparison

    Baseline to 3 months

  • Rate of Cardiovascular related Hospitalizations

    Between group comparison

    Through study completion, an average of 1 year

Study Arms (8)

Minneapolis Heart Institute

The Feinstein Institutes for Medical Research

NCH Baker Downtown Hospital

OhioHealth Research Institute

Baptist Health Baptist Hospital

St. Mary's Medical Center

Corewell Health William Beaumont University Hospital - Research Institute

University of Chicago Medicine

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a multicenter, retrospective case-control study which will collect data from all STEMI patients who received SSO2 treatment at participating centers, along with up to 3 matched control patients who did not receive SSO2 treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Baptist Hospital of Miami, Inc and Its Miami Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

NCH Healthcare System

Naples, Florida, 34102, United States

Location

Oakwood Healthcare, Inc

Dearborn, Michigan, 48124, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Northwell Health, Inc

Great Neck, New York, 11021, United States

Location

OhioHealth Research Institute

Columbus, Ohio, 43214, United States

Location

Avita Health

Galion, Ohio, 44833, United States

Location

St. Mary's Medical Center

Huntington, West Virginia, 25702, United States

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2023

First Posted

July 18, 2023

Study Start

July 31, 2023

Primary Completion

February 28, 2024

Study Completion

March 31, 2024

Last Updated

April 4, 2024

Record last verified: 2024-04

Locations