Trial Outcomes & Findings for ACCESS to the Cardiac Cath Lab in Patients Without STEMI Resuscitated From Out-of-hospital VT/VF Cardiac Arrest (NCT NCT03119571)

NCT ID: NCT03119571

Last Updated: 2021-01-27

Results Overview

Outcome is reported as the percent of participants who survive to hospital discharge with an mRS score less than or equal to 3. The Modified Rankin Score (mRS) is a 6-point scale measuring disability. Scores range from 0 (no disability) to 5 (severe disability; bedridden, incontinent, requires continuous care). Higher scores indicate greater disability. A sixth category is often added for patients who expire.

Recruitment status

TERMINATED

Study phase

Target enrollment

65 participants

Primary outcome timeframe

Up to 3 weeks

Results posted on

2021-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	Initial CCL Admission Admission to the CCL to evaluate the coronary artery disease Initial CCL admission: Admission to the cardiac catheterization lab to evaluated coronary artery disease and if present fix the culprit lesion/lesions	Initial ICU Admission Admission to the ICU to be evaluated by clinical team and the clinical treatment will be decided by the admitting/attending team. Initial ICU admission: Evaluate for additional testing and/or procedures
Overall Study STARTED	31	34
Overall Study COMPLETED	31	34
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ACCESS to the Cardiac Cath Lab in Patients Without STEMI Resuscitated From Out-of-hospital VT/VF Cardiac Arrest

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Initial CCL Admission n=31 Participants Admission to the CCL to evaluate the coronary artery disease Initial CCL admission: Admission to the cardiac catheterization lab to evaluated coronary artery disease and if present fix the culprit lesion/lesions	Initial ICU Admission n=34 Participants Admission to the ICU to be evaluated by clinical team and the clinical treatment will be decided by the admitting/attending team. Initial ICU admission: Evaluate for additional testing and/or procedures	Total n=65 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=99 Participants	22 Participants n=107 Participants	44 Participants n=206 Participants
Age, Categorical >=65 years	9 Participants n=99 Participants	12 Participants n=107 Participants	21 Participants n=206 Participants
Sex: Female, Male Female	8 Participants n=99 Participants	13 Participants n=107 Participants	21 Participants n=206 Participants
Sex: Female, Male Male	23 Participants n=99 Participants	21 Participants n=107 Participants	44 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=99 Participants	24 Participants n=107 Participants	48 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=99 Participants	9 Participants n=107 Participants	15 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	6 Participants n=99 Participants	4 Participants n=107 Participants	10 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	20 Participants n=99 Participants	29 Participants n=107 Participants	49 Participants n=206 Participants
Race (NIH/OMB) More than one race	4 Participants n=99 Participants	1 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment Canada	0 participants n=99 Participants	1 participants n=107 Participants	1 participants n=206 Participants
Region of Enrollment United States	31 participants n=99 Participants	33 participants n=107 Participants	64 participants n=206 Participants

PRIMARY outcome

Timeframe: Up to 3 weeks

Population: Of the 34 participants in the ICU group, 27 survived to discharge and 7 died. Of the 31 participants in the CCL group, 24 survived to discharge, and 7 died.

Outcome measures

Outcome measures
Measure	Initial CCL Admission n=24 Participants Admission to the CCL to evaluate the coronary artery disease Initial CCL admission: Admission to the cardiac catheterization lab to evaluated coronary artery disease and if present fix the culprit lesion/lesions	Initial ICU Admission n=27 Participants Admission to the ICU to be evaluated by clinical team and the clinical treatment will be decided by the admitting/attending team. Initial ICU admission: Evaluate for additional testing and/or procedures
Survival to Hospital Discharge With mRS ≤ 3	67.7 percentage of participants	73.5 percentage of participants

Adverse Events

Initial CCL Admission

Serious events: 12 serious events

Other events: 0 other events

Deaths: 7 deaths

Initial ICU Admission

Serious events: 18 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Initial CCL Admission n=31 participants at risk Admission to the CCL to evaluate the coronary artery disease Initial CCL admission: Admission to the cardiac catheterization lab to evaluated coronary artery disease and if present fix the culprit lesion/lesions	Initial ICU Admission n=34 participants at risk Admission to the ICU to be evaluated by clinical team and the clinical treatment will be decided by the admitting/attending team. Initial ICU admission: Evaluate for additional testing and/or procedures
Nervous system disorders Seizure Activity	6.5% 2/31 • Number of events 2 • Length of hospitalization, up to 3 weeks Before the trial started, a list of predefined adverse events was written in the study protocol for both groups. These events fall into 7 categories that were expected for this population. No additional adverse events were collected.	8.8% 3/34 • Number of events 3 • Length of hospitalization, up to 3 weeks Before the trial started, a list of predefined adverse events was written in the study protocol for both groups. These events fall into 7 categories that were expected for this population. No additional adverse events were collected.
Cardiac disorders Cardiac Arrest	12.9% 4/31 • Number of events 4 • Length of hospitalization, up to 3 weeks Before the trial started, a list of predefined adverse events was written in the study protocol for both groups. These events fall into 7 categories that were expected for this population. No additional adverse events were collected.	5.9% 2/34 • Number of events 2 • Length of hospitalization, up to 3 weeks Before the trial started, a list of predefined adverse events was written in the study protocol for both groups. These events fall into 7 categories that were expected for this population. No additional adverse events were collected.
Infections and infestations Infection/sepsis	29.0% 9/31 • Number of events 15 • Length of hospitalization, up to 3 weeks Before the trial started, a list of predefined adverse events was written in the study protocol for both groups. These events fall into 7 categories that were expected for this population. No additional adverse events were collected.	32.4% 11/34 • Number of events 16 • Length of hospitalization, up to 3 weeks Before the trial started, a list of predefined adverse events was written in the study protocol for both groups. These events fall into 7 categories that were expected for this population. No additional adverse events were collected.
Renal and urinary disorders Acute Kidney Injury	12.9% 4/31 • Number of events 4 • Length of hospitalization, up to 3 weeks Before the trial started, a list of predefined adverse events was written in the study protocol for both groups. These events fall into 7 categories that were expected for this population. No additional adverse events were collected.	20.6% 7/34 • Number of events 7 • Length of hospitalization, up to 3 weeks Before the trial started, a list of predefined adverse events was written in the study protocol for both groups. These events fall into 7 categories that were expected for this population. No additional adverse events were collected.
Hepatobiliary disorders Liver Failure/Injury	3.2% 1/31 • Number of events 1 • Length of hospitalization, up to 3 weeks Before the trial started, a list of predefined adverse events was written in the study protocol for both groups. These events fall into 7 categories that were expected for this population. No additional adverse events were collected.	5.9% 2/34 • Number of events 2 • Length of hospitalization, up to 3 weeks Before the trial started, a list of predefined adverse events was written in the study protocol for both groups. These events fall into 7 categories that were expected for this population. No additional adverse events were collected.
Cardiac disorders Cardiogenic Shock	22.6% 7/31 • Number of events 10 • Length of hospitalization, up to 3 weeks Before the trial started, a list of predefined adverse events was written in the study protocol for both groups. These events fall into 7 categories that were expected for this population. No additional adverse events were collected.	14.7% 5/34 • Number of events 5 • Length of hospitalization, up to 3 weeks Before the trial started, a list of predefined adverse events was written in the study protocol for both groups. These events fall into 7 categories that were expected for this population. No additional adverse events were collected.
General disorders Multiple Organ Dysfunction Syndrome (MODS)	3.2% 1/31 • Number of events 2 • Length of hospitalization, up to 3 weeks Before the trial started, a list of predefined adverse events was written in the study protocol for both groups. These events fall into 7 categories that were expected for this population. No additional adverse events were collected.	2.9% 1/34 • Number of events 2 • Length of hospitalization, up to 3 weeks Before the trial started, a list of predefined adverse events was written in the study protocol for both groups. These events fall into 7 categories that were expected for this population. No additional adverse events were collected.

Other adverse events

Adverse event data not reported

Additional Information

Demetri Yannopoulos, MD

University of Minnesota

Phone: 6126261382

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place