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Low enrollment, funding withdrawn
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To determine if survival to hospital discharge with good neurological outcome for adults ages 18-75 who are resuscitated from out-of-hospital VT/VF cardiac arrest without clinical signs of a heart attack do better by going straight to the cardiac catheterization laboratory or admitted to the intensive care unit for evaluation. The investigators think a large portion of resuscitated patients presenting with VT/VF have ischemic heart disease which is the cause for the arrest. And prompt access to the cardiac catheterization laboratory to reverse the blocked artery will improve survival with good neurological outcomes.
Primary Aim
Determine survival to hospital discharge with Modified Rankin Scale Score (mRS) ≤ 3 in adult (18-75 years old) patients resuscitated from out-of-hospital VT/VF cardiac arrest who do not have ST-segment elevation on emergency department 12-lead ECG (no-STEMI) randomized to receive either: 1) initial CCL admission, or 2) initial ICU admission.
Hypothesis: The corresponding hypothesis is that a large proportion of all resuscitated patients presenting with VT/VF have ischemic heart disease as the underlying cause for the participants cardiac arrest and that a strategy to facilitate prompt revascularization in all patients presenting with VT/VF who do not have ST-segment elevation on emergency department 12-lead ECG will improve survival with good neurological outcome.
Primary Endpoint
Survival to hospital discharge with mRS ≤ 3
Secondary Aims
Determine secondary assessments of survival, left ventricular function, hospital duration, and rehabilitation in-hospital and assessment of survival and functional status at 3 months in both groups.
Hypothesis: The corresponding hypothesis is that initial CCL admission will result in improved secondary assessment values at 3 months.
Secondary Endpoints
In-hospital secondary endpoints: Survival to hospital discharge, CPC score, mean peak troponin level, mean ejection fraction, mean length of ICU stay, mean hospitalization duration, the incidence of and mean length of rehabilitation.
3-month post-hospital discharge secondary endpoint: Survival to 3 months, survival to 3 months with mRS ≤ 3, functional status at 3 months (CPC score), incidence and length of rehabilitation, incidence of congestive heart failure, incidence of re-hospitalization over 3 months, and incidence and time to return to work.
Pragmatic Clinical Trial
The ACCESS Trial will randomize patients to receive one of two standard treatments currently practiced in the United States: either, 1) initial CCL admission, or 2) initial ICU admission. Other than randomizing to one of these two standard treatments, care is not otherwise specified and is completely at the discretion of the treating clinician, including coronary interventions, if any, hemodynamic support, medications, therapeutic hypothermia, and all other interventions and clinical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial CCL admission | Experimental | Admission to the CCL to evaluate the coronary artery disease |
|
| Initial ICU admission | Active Comparator | Admission to the ICU to be evaluated by clinical team and the clinical treatment will be decided by the admitting/attending team. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Initial CCL admission | Procedure | Admission to the cardiac catheterization lab to evaluated coronary artery disease and if present fix the culprit lesion/lesions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival to Hospital Discharge With mRS ≤ 3 | 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. | Up to 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Demetris Yannopoulos, MD | University of Minnesota | Principal Investigator |
| Tom Aufderheide, MD | MCW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States | ||
| Indiana University Health Methodist Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Initial ICU Admission |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2018 |
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| Initial ICU admission | Diagnostic Test | Evaluate for additional testing and/or procedures |
|
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| University Hospital | Ann Arbor | Michigan | 48109 | United States |
| St. Joseph Mercy Hospital | Ypsilanti | Michigan | 48197 | United States |
| North Memorial Medical Center | Brooklyn Center | Minnesota | 55429 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| University of Minnesota Medical Center, Fairview | Minneapolis | Minnesota | 55455 | United States |
| Methodist Hospital | Saint Louis Park | Minnesota | 55426 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| St. Joseph's Hospital | Saint Paul | Minnesota | 55102 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
| Miriam Hospital | Providence | Rhode Island | 02903 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Parkland Memorial Hospital | Dallas | Texas | 75235 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Virginia Commonwealth University Hospital | Richmond | Virginia | 23298 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Medical College of Wisconsin Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Vancouver General Hospital | Vancouver | British Columbia | V6Z 2K8 | Canada |
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 |
| COMPLETED |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Survival to Hospital Discharge With mRS ≤ 3 | 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. | 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. | Posted | Number | percentage of participants | Up to 3 weeks |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 7 | 31 | 12 | 31 | 0 | 31 |
| EG001 | 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 | 7 | 34 | 18 | 34 | 0 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection/sepsis | Infections and infestations | Systematic Assessment |
| ||
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Liver Failure/Injury | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cardiogenic Shock | Cardiac disorders | Systematic Assessment |
| ||
| Multiple Organ Dysfunction Syndrome (MODS) | General disorders | Systematic Assessment |
| ||
| Seizure Activity | Nervous system disorders | Systematic Assessment |
| ||
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Demetri Yannopoulos, MD | University of Minnesota | 6126261382 | yanno001@umn.edu |
| Nov 24, 2020 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Main Consent | Jan 3, 2019 | Nov 24, 2020 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Continued Participation Consent | Jan 3, 2019 | Nov 24, 2020 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D014693 | Ventricular Fibrillation |
| D006323 | Heart Arrest |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
|