ACCESS to the Cardiac Cath Lab in Patients Without STEMI Resuscitated From Out-of-hospital VT/VF Cardiac Arrest
Status: | Recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 3/15/2019 |
Start Date: | December 12, 2017 |
End Date: | December 2021 |
Contact: | Demetris Yannopoulos, MD |
Email: | yanno001@umn.edu |
Phone: | 6126261382 |
ACCESS to the Cardiac Catheterization Laboratory in Patients Without ST-segment Elevation Myocardial Infarction Resuscitated From Out-of-hospital Ventricular Fibrillation Cardiac Arrest
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.
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.
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.
Inclusion Criteria:
- Adult presumed or known to be 18-75 years old
- Resuscitated from OOHCA
- Initial cardiac arrest rhythm of pulseless VT/VF (including patients treated with an
AED)
- No ST-segment elevation MI (No STEMI) (or STEMI-equivalent syndrome) on ED 12-lead ECG
(as interpreted by a physician)
Exclusion Criteria:
- Initial non-shockable out-of-hospital cardiac arrest rhythm (pulseless electrical
activity or asystole)
- Valid do not resuscitate orders (DNR),
- Blunt, penetrating, or burn-related injury, drowning, electrocution or known overdose,
- Known prisoners
- Known pregnancy,
- ST-segment elevation on ED 12-lead ECG (as interpreted by a physician)
- Absolute contraindications to emergent coronary angiography including,
- known anaphylactic reaction to angiographic contrast media,
- active gastrointestinal or internal bleeding, or
- severe concomitant illness that drastically shortens life expectancy or increases risk
of the procedure.
- Suspected or confirmed intracranial bleeding
- Refractory cardiac arrest (prior to randomization)
- Patients meeting ACCESS Trial eligibility criteria initially seen in an outside
hospital and then transferred to an ACCESS Trial participating hospital
We found this trial at
17
sites
2450 Riverside Ave
Minneapolis, Minnesota 55454
Minneapolis, Minnesota 55454
(612) 273-3000
Principal Investigator: Demetris Yannopoulos, MD
University of Minnesota Medical Center, Fairview Improving patients' lives drives the innovation that makes University...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Clifton Callaway, MD
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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593 Eddy Street
Providence, Rhode Island 02903
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Lisa Merck, MD
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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201 Presidents Circle
Salt Lake City, Utah 84108
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Scott Youngquist, MD
University of Utah Research is a major component in the life of the U benefiting...
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80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
Atlanta, Georgia 30303
(404) 616-1000
Principal Investigator: Lekshmi Kumar, MD
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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2600 Clifton Ave
Cincinnati, Ohio 45267
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Justin Benoit, MD
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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5201 Harry Hines Blvd
Dallas, Texas 75235
Dallas, Texas 75235
(214) 590-8000
Principal Investigator: Ahamed Idris, MD
Parkland Memorial Hospital As our community's public health system, Parkland is the foundation for a...
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Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Indianapolis, Indiana 46202
Principal Investigator: Ben Hunter, MD
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Milwaukee, Wisconsin 53226
Principal Investigator: Tom Aufderheide, MD
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164 Summit Ave
Providence, Rhode Island 02906
Providence, Rhode Island 02906
(401) 793-2500
Principal Investigator: Lisa Merck, MD
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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640 Jackson Street
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
651-254-3456
Principal Investigator: Johannes Brechtken, MD
Regions Hospital Established in 1872, Regions Hospital is a private, not-for-profit organization. The hospital provides...
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45 10th Street East
Saint Paul, Minnesota 55102
Saint Paul, Minnesota 55102
Principal Investigator: Carmello Panetta, MD
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