Trial Outcomes & Findings for Cost Comparison of Cardiac Magnetic Resonance Imaging (MRI) Use in Emergency Department (ED) Patients With Chest Pain (NCT NCT00678639)

NCT ID: NCT00678639

Last Updated: 2018-09-11

Results Overview

Index hospitalization refers to the hospital visit during which the participant was enrolled in the trial. The primary outcome is examining the cost for this visit.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 110 participants
• Primary outcome timeframe: Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours
• Results posted on: 2018-09-11

Participant Flow

Participants were recruited from the emergency department January 2008 - March 2009.

Once consented, no participants were excluded from the trial prior to group assignment.

Participant milestones

Measure	Emergency Department (ED) Observation Unit Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.	Usual Care This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
Overall Study STARTED	53	57
Overall Study Hospital Discharge	53	57
Overall Study COMPLETED	51	57
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Emergency Department (ED) Observation Unit Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.	Usual Care This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
Overall Study Lost to Follow-up at 30 days	2	0

Baseline Characteristics

Cost Comparison of Cardiac Magnetic Resonance Imaging (MRI) Use in Emergency Department (ED) Patients With Chest Pain

Baseline characteristics by cohort

Measure	Emergency Department (ED) Observation Unit n=53 Participants Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.	Usual Care n=57 Participants This is the comparison arm. Patients are admitted to the hospital and undergo usual care.	Total n=110 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	45 Participants n=5 Participants	47 Participants n=7 Participants	92 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	27 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	30 Participants n=7 Participants	55 Participants n=5 Participants
Region of Enrollment United States	53 participants n=5 Participants	57 participants n=7 Participants	110 participants n=5 Participants

PRIMARY outcome

Timeframe: Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours

Population: All participants were analyzed based on intention to treat.

Index hospitalization refers to the hospital visit during which the participant was enrolled in the trial. The primary outcome is examining the cost for this visit.

Outcome measures

Measure	Emergency Department (ED) Observation Unit n=53 Participants Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.	Usual Care n=57 Participants This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
Cost of Index Hospitalization	2062 US Dollars Interval 1918.0 to 2367.0	2680 US Dollars Interval 2408.0 to 3448.0

SECONDARY outcome

Timeframe: 30 Days

Population: 4 participants (3 in the usual care group and 1 in the ED obs unit group) left Against Medical Advice (AMA) prior to completion of their evaluation and were excluded from this analysis. Analysis was per intention to treat.

Participants with ACS and admitted or not experiencing ACS and discharged will be considered a correct admission decision. Remaining participants will be considered to have incorrect admission decisions.

Outcome measures

Measure	Emergency Department (ED) Observation Unit n=52 Participants Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.	Usual Care n=54 Participants This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
Correct Admission Decision, Based Upon the Reference Standard of Acute Coronary Syndrome (ACS) at 30 Days	43 Participants	6 Participants

SECONDARY outcome

Timeframe: Emergency Department (ED) arrival through hospital discharge

Population: All participants randomized to the Observation Unit - Cardiac Magnetic Resonance Imaging (OU-CMR) arm were analyzed based on intention to treat.

The number of participants able to complete the planned imaging sequences will be measured.

Outcome measures

Measure	Emergency Department (ED) Observation Unit n=53 Participants Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.	Usual Care This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
The Number of Participants Randomized to the OU and Were Able to Complete CMR Imaging	46 Participants	—

SECONDARY outcome

Timeframe: 30d, 3mo, 6mo, and 1 year

Population: Data reported through 30 days. Follow-up with participants is ongoing. Results will be updated once follow-up is complete.

Measured as self report, assessed during telephone follow-up.

Outcome measures

Measure	Emergency Department (ED) Observation Unit n=53 Participants Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.	Usual Care n=57 Participants This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
Number of Participants Who Utilized the Indicated Health Care Procedures Resting Echocardiogram	0 Participants	1 Participants
Number of Participants Who Utilized the Indicated Health Care Procedures Cardiac related office visit	7 Participants	4 Participants
Number of Participants Who Utilized the Indicated Health Care Procedures Cardiac related ED visit	0 Participants	4 Participants
Number of Participants Who Utilized the Indicated Health Care Procedures Cardiac related hospitalization	0 Participants	3 Participants
Number of Participants Who Utilized the Indicated Health Care Procedures Cardiac related procedures	0 Participants	4 Participants
Number of Participants Who Utilized the Indicated Health Care Procedures Cardiac Catheterization	0 Participants	3 Participants
Number of Participants Who Utilized the Indicated Health Care Procedures Stress Test	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Occuring in the MRI scanning suite or within 30 minutes of the last image acquisition.

Population: Only participants undergoing Cardiac MRI scanning are eligible for this endpoint. Only 49 of the 53 participants randomized to observation unit arm underwent CMR testing. Nine participants in the usual care arm underwent CMR testing.

Any event leading to early termination of the MRI acquisition, or requiring intervention by a physician, will be considered an adverse event related to MRI, excluding physician termination of image acquisition due to concerns of cardiac ischemia.

Outcome measures

Measure	Emergency Department (ED) Observation Unit n=49 Participants Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.	Usual Care n=9 Participants This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
Adverse Events During Magnetic Resonance Imaging (MRI) Scanning	3 Participants	1 Participants

Adverse Events

Emergency Department (ED) Observation Unit

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Usual Care

Serious events: 7 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Emergency Department (ED) Observation Unit n=53 participants at risk Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.	Usual Care n=57 participants at risk This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
Gastrointestinal disorders Hospitalization for abdominal pain due to cholecystitis	1.9% 1/53 • Number of events 1 • The reported adverse event data was collected from participant enrollment through 90 days. Adverse event assessment is ongoing and will be updated when follow-up is complete.	0.00% 0/57 • The reported adverse event data was collected from participant enrollment through 90 days. Adverse event assessment is ongoing and will be updated when follow-up is complete.
Nervous system disorders Hospitalization for cerebral infarct	0.00% 0/53 • The reported adverse event data was collected from participant enrollment through 90 days. Adverse event assessment is ongoing and will be updated when follow-up is complete.	1.8% 1/57 • Number of events 1 • The reported adverse event data was collected from participant enrollment through 90 days. Adverse event assessment is ongoing and will be updated when follow-up is complete.
Cardiac disorders Hospitalization for chest pain	0.00% 0/53 • The reported adverse event data was collected from participant enrollment through 90 days. Adverse event assessment is ongoing and will be updated when follow-up is complete.	8.8% 5/57 • Number of events 6 • The reported adverse event data was collected from participant enrollment through 90 days. Adverse event assessment is ongoing and will be updated when follow-up is complete.
Psychiatric disorders Hospitalization for chest pain and suicidal ideation	0.00% 0/53 • The reported adverse event data was collected from participant enrollment through 90 days. Adverse event assessment is ongoing and will be updated when follow-up is complete.	1.8% 1/57 • Number of events 1 • The reported adverse event data was collected from participant enrollment through 90 days. Adverse event assessment is ongoing and will be updated when follow-up is complete.
Surgical and medical procedures Hospitalization for neck surgery	1.9% 1/53 • Number of events 1 • The reported adverse event data was collected from participant enrollment through 90 days. Adverse event assessment is ongoing and will be updated when follow-up is complete.	0.00% 0/57 • The reported adverse event data was collected from participant enrollment through 90 days. Adverse event assessment is ongoing and will be updated when follow-up is complete.

Other adverse events

Measure	Emergency Department (ED) Observation Unit n=53 participants at risk Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.	Usual Care n=57 participants at risk This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
Investigations Excessive cost of cardiac testing without Acute Coronary Syndrome (ACS)	9.4% 5/53 • Number of events 5 • The reported adverse event data was collected from participant enrollment through 90 days. Adverse event assessment is ongoing and will be updated when follow-up is complete.	1.8% 1/57 • Number of events 1 • The reported adverse event data was collected from participant enrollment through 90 days. Adverse event assessment is ongoing and will be updated when follow-up is complete.
Social circumstances Participant left before evaluation was completed	1.9% 1/53 • Number of events 1 • The reported adverse event data was collected from participant enrollment through 90 days. Adverse event assessment is ongoing and will be updated when follow-up is complete.	5.3% 3/57 • Number of events 3 • The reported adverse event data was collected from participant enrollment through 90 days. Adverse event assessment is ongoing and will be updated when follow-up is complete.

Additional Information

Chadwick Miller, MD

Wake Forest University Baptist Medical Center

Phone: 336-716-1740

Email: cmiller@wfubmc.edu

Results disclosure agreements

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