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

Primary Purpose

Acute Coronary Syndrome, Myocardial Infarction, Unstable Angina Pectoris

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Cardiac Computed Tomography

About this trial

This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring acute chest pain, emergency department, cardiac computed tomography

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participant had at least five minutes of chest pain or equivalent (chest tightness; pain radiating to left, right, or both arms or shoulders, back, neck, epigastrium, jaw/throat; or unexplained shortness of breath, syncope/presyncope, generalized weakness, nausea, or vomiting thought to be of cardiac origin) at rest or during exercise within 24 hours of ED presentation, warranting further risk stratification, as determined by an ED attending.
2 or more cardiac risk factors (diabetes, hypertension, hyperlipidemia, current smoker and family history of coronary artery disease).
Able to provide a written informed consent.
<75 years of age, but >40 years of age.
Able to hold breath for at least 10 seconds.
Sinus rhythm.

Exclusion Criteria:

New diagnostic ischemic ECG changes (ST-segment elevation or depression > 1 mm or T-wave inversion > 4 mm) in more than two anatomically adjacent leads or left bundle branch block
Documented or self-reported history of CAD (MI, percutaneous coronary interventions [PCIs], coronary artery bypass graft [CABG], known significant coronary stenosis [>50%])
Greater than 6 hours since presentation to ED.
BMI >40 kg/m2
Impaired renal function as defined by serum creatinine >1.5 mg/dL*
Elevated troponin-T (> 0.09 ng/ml)
Hemodynamically or clinically unstable condition (BP systolic < 80 mm Hg, atrial or ventricular arrhythmias, persistent chest pain despite adequate therapy)
Known allergy to iodinated contrast agent
Currently symptomatic asthma
Documented or self-reported cocaine use within the past 48 hours (acute)
On Metformin therapy and unable or unwilling to discontinue for 48 hours after the CT scan
Contraindication to beta blockers (taking daily antiasthmatic medication): This exclusion only applies to patients with a heart rate >65 bpm at sites using a non-dual source CT scanner
Participant with no telephone or cell phone numbers or no address (preventing follow-up)
Participant with positive pregnancy test. Women of childbearing potential, defined as <2 years of menopause in the absence of hysterectomy or tube ligation, must have a pregnancy test performed within 24 hours before the CT scan.
Participant unwilling to provide a written informed consent.

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of care

Cardiac CT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Length of Hospital Stay

Secondary Outcome Measures

Time to Diagnosis

Healthcare Utilization

Number of patients with diagnostic testing (CCTA, ETT, SPECT, stress echocardiography, and invasive coronary angiography)

MACE

Major Adverse Cardiovascular Events, All though these events are called MACE they do not qualify as adverse or serious adverse events. As these events are expected in some individuals in this population. Only MACE that occured within 72 hours after hospital discharge were considered serious adverse events in this trial. There were no such events.

Cost-effectiveness

Total cost during index hospitalization

Rate of ED Discharge

Direct discharge from Emergency Department

Full Information

NCT ID

NCT01084239

First Posted

January 7, 2010

Last Updated

April 8, 2014

Sponsor

Massachusetts General Hospital

Collaborators

National Heart, Lung, and Blood Institute (NHLBI), Kaiser Permanente, Beth Israel Deaconess Medical Center, Bay State Clinical Trials, Inc., Washington University School of Medicine, Tufts Medical Center, The Cleveland Clinic, Northwestern University, University of Maryland

1. Study Identification

Unique Protocol Identification Number

NCT01084239

Brief Title

Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography

Acronym

ROMICAT-II

Official Title

Rule Out Myocardial Ischemia/Infarction by Computer Assisted Tomography

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The growing availability of cardiac computed tomography (CT)* in emergency departments (EDs) across the U.S. expands the opportunities for its clinical application, but also heightens the need to define its appropriate use in the evaluation of patients with acute chest pain. To address this need, we performed a randomized diagnostic trial (RDT) to determine whether integrating cardiac CT, along with the information it provides on coronary artery disease (CAD) and left ventricular (LV) function, can improve the efficiency of the management of these patients (i.e. shorten length of hospital stay, increase direct discharge rates from the ED, decreasing healthcare costs and improving cost effectiveness while being safe).

Detailed Description

Patients with acute chest pain and normal or non-diagnostic electrocardiograms (ECGs) represent a cohort whose management is notably inefficient and diagnostically challenging. Because in less than 30% of EDs diagnostic testing (e.g. nuclear imaging, echocardiography, and exercise treadmill ECG) that would allow physicians to rule out the occurrence of myocardial ischemia is performed as part of the initial evaluation, most of these patients are hospitalized for 24 to 36 hours to exclude the presence of acute coronary syndrome (ACS). Of the six million acute chest pain patients admitted each year in the U.S. under these conditions, less than 10% of them ultimately receive a diagnosis of ACS at discharge. Moreover, inpatient care for negative evaluations imparts an economic burden in excess of $8 billion annually. Since acute myocardial ischemia and necrosis are rare in the absence of coronary artery disease, a technology that reliably identifies CAD may allow physicians to discharge chest pain patients directly from the ED. Cardiac CT is a safe, high-speed, noninvasive imaging technique that accurately detects coronary atherosclerotic plaque and stenosis, and also allows physicians to assess global and regional LV function. Observational studies have demonstrated that approximately 40% of acute chest pain patients have no evidence of atherosclerosis on cardiac CT, and that an additional 30% have no evidence of hemodynamically significant (>50%) coronary artery stenosis. Both of these criteria are powerful predictors of the absence of both ACS and major adverse cardiovascular events (negative predictive value [NPV] of 98%). The specificity of cardiac CT is further increased when global and regional LV function is normal. Several studies have demonstrated that cardiac CT, with its high NPV, can be effectively used to rule out ACS, but little is known about the willingness ability of ED physicians to use this information to augment patient management. We therefore performed a trial at 9 clinical sites and randomized 1000 patients with acute chest pain and normal or non-diagnostic ECGs, to receive either standard ED evaluation (no intervention) or a cardiac CT (experimental) in the evaluation of acute chest pain in the emergency room. (Rule Out Myocardial Infarction using Computer Assisted Computed Tomography [ROMICAT II]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome, Myocardial Infarction, Unstable Angina Pectoris

Keywords

acute chest pain, emergency department, cardiac computed tomography

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of care

Arm Type

No Intervention

Arm Description

Arm Title

Cardiac CT

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Cardiac Computed Tomography

Intervention Description

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.

Primary Outcome Measure Information:

Title

Length of Hospital Stay

Time Frame

Duration of stay in the hospital during the initial visit

Secondary Outcome Measure Information:

Title

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 ).

Title

Healthcare Utilization

Description

Number of patients with diagnostic testing (CCTA, ETT, SPECT, stress echocardiography, and invasive coronary angiography)

Time Frame

Duration of stay in the hospital during the initial visit

Title

MACE

Description

Time Frame

72 hours after discharge up to 28 days after enrollment.

Title

Cost-effectiveness

Description

Total cost during index hospitalization

Time Frame

Duration of stay in the hospital during the initial visit

Title

Rate of ED Discharge

Description

Direct discharge from Emergency Department

Time Frame

Duration of stay in the hospital during the initial visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participant had at least five minutes of chest pain or equivalent (chest tightness; pain radiating to left, right, or both arms or shoulders, back, neck, epigastrium, jaw/throat; or unexplained shortness of breath, syncope/presyncope, generalized weakness, nausea, or vomiting thought to be of cardiac origin) at rest or during exercise within 24 hours of ED presentation, warranting further risk stratification, as determined by an ED attending. 2 or more cardiac risk factors (diabetes, hypertension, hyperlipidemia, current smoker and family history of coronary artery disease). Able to provide a written informed consent. <75 years of age, but >40 years of age. Able to hold breath for at least 10 seconds. Sinus rhythm. Exclusion Criteria: New diagnostic ischemic ECG changes (ST-segment elevation or depression > 1 mm or T-wave inversion > 4 mm) in more than two anatomically adjacent leads or left bundle branch block Documented or self-reported history of CAD (MI, percutaneous coronary interventions [PCIs], coronary artery bypass graft [CABG], known significant coronary stenosis [>50%]) Greater than 6 hours since presentation to ED. BMI >40 kg/m2 Impaired renal function as defined by serum creatinine >1.5 mg/dL* Elevated troponin-T (> 0.09 ng/ml) Hemodynamically or clinically unstable condition (BP systolic < 80 mm Hg, atrial or ventricular arrhythmias, persistent chest pain despite adequate therapy) Known allergy to iodinated contrast agent Currently symptomatic asthma Documented or self-reported cocaine use within the past 48 hours (acute) On Metformin therapy and unable or unwilling to discontinue for 48 hours after the CT scan Contraindication to beta blockers (taking daily antiasthmatic medication): This exclusion only applies to patients with a heart rate >65 bpm at sites using a non-dual source CT scanner Participant with no telephone or cell phone numbers or no address (preventing follow-up) Participant with positive pregnancy test. Women of childbearing potential, defined as <2 years of menopause in the absence of hysterectomy or tube ligation, must have a pregnancy test performed within 24 hours before the CT scan. Participant unwilling to provide a written informed consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Udo Hoffmann, MD, MPH

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33766254

Citation

Karady J, Mayrhofer T, Ferencik M, Nagurney JT, Udelson JE, Kammerlander AA, Fleg JL, Peacock WF, Januzzi JL Jr, Koenig W, Hoffmann U. Discordance of High-Sensitivity Troponin Assays in Patients With Suspected Acute Coronary Syndromes. J Am Coll Cardiol. 2021 Mar 30;77(12):1487-1499. doi: 10.1016/j.jacc.2021.01.046.

Results Reference

derived

PubMed Identifier

30405295

Citation

Reinhardt SW, Babatunde A, Novak E, Brown DL. Effect of Race on Outcomes Following Early Coronary Computed Tomographic Angiography or Standard Emergency Department Evaluation for Acute Chest Pain. Ethn Dis. 2018 Oct 18;28(4):517-524. doi: 10.18865/ed.28.4.517. eCollection 2018 Fall.

Results Reference

derived

PubMed Identifier

30354493

Citation

Bittner DO, Mayrhofer T, Puchner SB, Lu MT, Maurovich-Horvat P, Ghemigian K, Kitslaar PH, Broersen A, Bamberg F, Truong QA, Schlett CL, Hoffmann U, Ferencik M. Coronary Computed Tomography Angiography-Specific Definitions of High-Risk Plaque Features Improve Detection of Acute Coronary Syndrome. Circ Cardiovasc Imaging. 2018 Aug;11(8):e007657. doi: 10.1161/CIRCIMAGING.118.007657.

Results Reference

derived

PubMed Identifier

29138794

Citation

Reinhardt SW, Lin CJ, Novak E, Brown DL. Noninvasive Cardiac Testing vs Clinical Evaluation Alone in Acute Chest Pain: A Secondary Analysis of the ROMICAT-II Randomized Clinical Trial. JAMA Intern Med. 2018 Feb 1;178(2):212-219. doi: 10.1001/jamainternmed.2017.7360.

Results Reference

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PubMed Identifier

28923845

Citation

Ferencik M, Mayrhofer T, Lu MT, Woodard PK, Truong QA, Peacock WF, Bamberg F, Sun BC, Fleg JL, Nagurney JT, Udelson JE, Koenig W, Januzzi JL, Hoffmann U. High-Sensitivity Cardiac Troponin I as a Gatekeeper for Coronary Computed Tomography Angiography and Stress Testing in Patients with Acute Chest Pain. Clin Chem. 2017 Nov;63(11):1724-1733. doi: 10.1373/clinchem.2017.275552. Epub 2017 Sep 18.

Results Reference

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PubMed Identifier

28487318

Citation

Bittner DO, Mayrhofer T, Bamberg F, Hallett TR, Janjua S, Addison D, Nagurney JT, Udelson JE, Lu MT, Truong QA, Woodard PK, Hollander JE, Miller C, Chang AM, Singh H, Litt H, Hoffmann U, Ferencik M. Impact of Coronary Calcification on Clinical Management in Patients With Acute Chest Pain. Circ Cardiovasc Imaging. 2017 May;10(5):e005893. doi: 10.1161/CIRCIMAGING.116.005893.

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PubMed Identifier

27006119

Citation

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.

Results Reference

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PubMed Identifier

26762723

Citation

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.

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PubMed Identifier

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Citation

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.

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PubMed Identifier

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Citation

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.

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Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography

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