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
NA
Target enrollment
65 participants
Primary outcome timeframe
Up to 3 weeks
Results posted on
2021-01-27
Participant Flow
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
| 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=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
33 participants
n=7 Participants
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 weeksPopulation: 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 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.
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
| 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
|
|---|---|---|
|
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.
|
|
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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place