Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
Conditions:	Acute Coronary Syndrome Myocardial Infarction Unstable Angina Pectoris
Intervention:	Radiation: Cardiac Computed Tomography

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patient enrollment began on April 23, 2010, and ended on January 30, 2012, at nine hospitals in the United States.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Cardiac CT	Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department. Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings.
Standard of Care	Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.

Description

Cardiac CT

Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.

Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings.

Standard of Care

Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.

Participant Flow for 2 periods

Period 1: Randomization - Index Hospitalization

	Cardiac CT	Standard of Care
STARTED	501	499
COMPLETED	501	499
NOT COMPLETED	0	0

Period 2: 28-Day Follow-up

	Cardiac CT	Standard of Care
STARTED	501 ^[1]	499
COMPLETED	497	490
NOT COMPLETED	4	9
Lost to Follow-up	4	9

^[1]	All 501 patients enrolled were evaluated for follow-up at 28 days.

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Cardiac CT	Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department. Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings.
Standard of Care	Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
Total	Total of all reporting groups

Description

Cardiac CT

Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.

Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings.

Standard of Care

Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.

Total

Total of all reporting groups

Baseline Measures

	Cardiac CT	Standard of Care	Total
Overall Participants Analyzed [Units: Participants]	501	499	1000

Age [Units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	433	440	873
>=65 years	68	59	127

Age [Units: Years] Mean (Standard Deviation)	54 (8)	54 (8)	54 (8)

Gender [Units: Participants]
Female	239	229	468
Male	262	270	532

Region of Enrollment [Units: Participants]
United States	501	499	1000

Outcome Measures

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1. Primary:

Length of Hospital Stay [ Time Frame: Duration of stay in the hospital during the initial visit ]

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2. Secondary:

Time to Diagnosis [ Time Frame: Time from ED arrival to first positive test (all tests except Echocardiography Rest and including troponins ) if discharge diagnosis is ACS, otherwise time to performance of last test (all tests except Echocardiography Rest and including troponins ). ]

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3. Secondary:

Healthcare Utilization [ Time Frame: Duration of stay in the hospital during the initial visit ]

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4. Secondary:

MACE [ Time Frame: 72 hours after discharge up to 28 days after enrollment. ]

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5. Secondary:

Cost-effectiveness [ Time Frame: Duration of stay in the hospital during the initial visit ]

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6. Secondary:

Rate of ED Discharge [ Time Frame: Duration of stay in the hospital during the initial visit ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Enrollment occurred only during weekday hours. Lack of blinding to the intervention. Results may not be applicable to populations we did not study (i.e. patients younger than 40 years of age and those older than 74 years of age).

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

Enrollment occurred only during weekday hours.

Lack of blinding to the intervention.

Results may not be applicable to populations we did not study (i.e. patients younger than 40 years of age and those older than 74 years of age).

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Pearl Zakroysky
Organization: Massachusetts Genderal Hospital Biostatistics Center
phone: 617 724 0309
e-mail: pzakroysky@partners.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Truong QA, Schulman-Marcus J, Zakroysky P, Chou ET, Nagurney JT, Fleg JL, Schoenfeld DA, Udelson JE, Hoffmann U, Woodard PK. Coronary CT Angiography Versus Standard Emergency Department Evaluation for Acute Chest Pain and Diabetic Patients: Is There Benefit With Early Coronary CT Angiography? Results of the Randomized Comparative Effectiveness ROMICAT II Trial. J Am Heart Assoc. 2016 Mar 22;5(3):e003137. doi: 10.1161/JAHA.115.003137.

Pursnani A, Celeng C, Schlett CL, Mayrhofer T, Zakroysky P, Lee H, Ferencik M, Fleg JL, Bamberg F, Wiviott SD, Truong QA, Udelson JE, Nagurney JT, Hoffmann U. Use of Coronary Computed Tomographic Angiography Findings to Modify Statin and Aspirin Prescription in Patients With Acute Chest Pain. Am J Cardiol. 2016 Feb 1;117(3):319-24. doi: 10.1016/j.amjcard.2015.10.052. Epub 2015 Nov 18.

Ferencik M, Liu T, Mayrhofer T, Puchner SB, Lu MT, Maurovich-Horvat P, Pope JH, Truong QA, Udelson JE, Peacock WF, White CS, Woodard PK, Fleg JL, Nagurney JT, Januzzi JL, Hoffmann U. hs-Troponin I Followed by CT Angiography Improves Acute Coronary Syndrome Risk Stratification Accuracy and Work-Up in Acute Chest Pain Patients: Results From ROMICAT II Trial. JACC Cardiovasc Imaging. 2015 Nov;8(11):1272-1281. doi: 10.1016/j.jcmg.2015.06.016. Epub 2015 Oct 14.

Januzzi JL, Sharma U, Zakroysky P, Truong QA, Woodard PK, Pope JH, Hauser T, Mayrhofer T, Nagurney JT, Schoenfeld D, Peacock WF, Fleg JL, Wiviott S, Pang PS, Udelson J, Hoffmann U. Sensitive troponin assays in patients with suspected acute coronary syndrome: Results from the multicenter rule out myocardial infarction using computer assisted tomography II trial. Am Heart J. 2015 Apr;169(4):572-8.e1. doi: 10.1016/j.ahj.2014.12.023. Epub 2015 Jan 9.

Pursnani A, Chou ET, Zakroysky P, Deaño RC, Mamuya WS, Woodard PK, Nagurney JT, Fleg JL, Lee H, Schoenfeld D, Udelson JE, Hoffmann U, Truong QA. Use of coronary artery calcium scanning beyond coronary computed tomographic angiography in the emergency department evaluation for acute chest pain: the ROMICAT II trial. Circ Cardiovasc Imaging. 2015 Mar;8(3). pii: e002225. doi: 10.1161/CIRCIMAGING.114.002225. Epub 2015 Feb 20.

Puchner SB, Liu T, Mayrhofer T, Truong QA, Lee H, Fleg JL, Nagurney JT, Udelson JE, Hoffmann U, Ferencik M. High-risk plaque detected on coronary CT angiography predicts acute coronary syndromes independent of significant stenosis in acute chest pain: results from the ROMICAT-II trial. J Am Coll Cardiol. 2014 Aug 19;64(7):684-92. doi: 10.1016/j.jacc.2014.05.039.

Truong QA, Hayden D, Woodard PK, Kirby R, Chou ET, Nagurney JT, Wiviott SD, Fleg JL, Schoenfeld DA, Udelson JE, Hoffmann U. Sex differences in the effectiveness of early coronary computed tomographic angiography compared with standard emergency department evaluation for acute chest pain: the rule-out myocardial infarction with Computer-Assisted Tomography (ROMICAT)-II Trial. Circulation. 2013 Jun 25;127(25):2494-502. doi: 10.1161/CIRCULATIONAHA.113.001736. Epub 2013 May 17.

Hoffmann U, Truong QA, Schoenfeld DA, Chou ET, Woodard PK, Nagurney JT, Pope JH, Hauser TH, White CS, Weiner SG, Kalanjian S, Mullins ME, Mikati I, Peacock WF, Zakroysky P, Hayden D, Goehler A, Lee H, Gazelle GS, Wiviott SD, Fleg JL, Udelson JE; ROMICAT-II Investigators. Coronary CT angiography versus standard evaluation in acute chest pain. N Engl J Med. 2012 Jul 26;367(4):299-308. doi: 10.1056/NEJMoa1201161.

Hoffmann U, Truong QA, Fleg JL, Goehler A, Gazelle S, Wiviott S, Lee H, Udelson JE, Schoenfeld D; ROMICAT II. Design of the Rule Out Myocardial Ischemia/Infarction Using Computer Assisted Tomography: a multicenter randomized comparative effectiveness trial of cardiac computed tomography versus alternative triage strategies in patients with acute chest pain in the emergency department. Am Heart J. 2012 Mar;163(3):330-8, 338.e1. doi: 10.1016/j.ahj.2012.01.028. Epub 2012 Feb 22.

Responsible Party:	Udo Hoffmann, MD MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01084239 History of Changes
Other Study ID Numbers:	2009P002331
Study First Received:	January 7, 2010
Results First Received:	September 9, 2013
Last Updated:	April 8, 2014

Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography (ROMICAT-II)