Trial Outcomes & Findings for Verification of Prediction Algorithm (NCT NCT02863666)

NCT ID: NCT02863666

Last Updated: 2024-05-13

Results Overview

The number of any cardiopulmonary event, not limited to: Cardiac arrest Sustained ventricular tachycardia (VT) Hypotension requiring inotropes or intra-aortic balloon pump (IABP) insertion Intubation or mechanical ventilation Complete heart block Bradycardia requiring insertion of a pacing wire or external pacing, and Percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG)

• Recruitment status: COMPLETED
• Target enrollment: 673 participants
• Primary outcome timeframe: Within 72 hours of presentation to ED
• Results posted on: 2024-05-13

Participant Flow

Participant milestones

Measure	Enrolled Enrolled subjects in observational study
Overall Study STARTED	673
Overall Study COMPLETED	673
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Verification of Prediction Algorithm

Baseline characteristics by cohort

Measure	Enrolled n=673 Participants Enrolled subjects in observational study
Age, Continuous	58.8 years STANDARD_DEVIATION 14.95 • n=5 Participants
Sex: Female, Male Female	304 Participants n=5 Participants
Sex: Female, Male Male	369 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	665 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	167 Participants n=5 Participants
Race (NIH/OMB) White	471 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	29 Participants n=5 Participants
Region of Enrollment Belgium	253 participants n=5 Participants
Region of Enrollment United States	420 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 72 hours of presentation to ED

The number of any cardiopulmonary event, not limited to:

Cardiac arrest Sustained ventricular tachycardia (VT) Hypotension requiring inotropes or intra-aortic balloon pump (IABP) insertion Intubation or mechanical ventilation Complete heart block Bradycardia requiring insertion of a pacing wire or external pacing, and Percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG)

Outcome measures

Measure	Enrolled n=673 Participants Enrolled subjects in observational study
Number of Subjects With a Cardiopulmonary Event	145 Participants

SECONDARY outcome

Timeframe: Within 72 hours of presentation to ED

The cumulative number of any cardiac and cardiac-related events, not limited to:

In-hospital Death In-hospital Cardiac Arrest Composite cardiovascular outcome or intervention (Lethal Arrhythmias , Acute Pulmonary Edema, Cardiogenic Shock, Myocardial Infarction, Percutaneous Coronary Intervention, Coronary artery Bypass Surgery , New or Recurrent MI, Recurrent Ischemia requiring Revascularization)

Outcome measures

Outcome data not reported

Adverse Events

Enrolled

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Enrolled n=673 participants at risk Enrolled subjects in observational study
Respiratory, thoracic and mediastinal disorders Respiratory	0.74% 5/673 • Number of events 5 • 1 year, 4 months

Additional Information

Brooke Lerner PHD,

University of Buffalo

Phone: 716.390.3509

Email: lerner@buffalo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place