Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography

NCT01084239 | Completed Phase 3 Results DMC

• 1 other identifier: 2009P002331
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Coronary Syndrome; Myocardial Infarction; Unstable Angina Pectoris

Keywords

acute chest pain; emergency department; cardiac computed tomography

Outcome Measures

Primary Outcomes (1)

• Length of Hospital Stay

  Duration of stay in the hospital during the initial visit

Secondary Outcomes (5)

• Time to Diagnosis

  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 ).

• Healthcare Utilization

  Duration of stay in the hospital during the initial visit

• MACE

  72 hours after discharge up to 28 days after enrollment.

• Cost-effectiveness

  Duration of stay in the hospital during the initial visit

• Rate of ED Discharge

  Duration of stay in the hospital during the initial visit

Study Arms (2)

Standard of care

NO INTERVENTION

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.

Cardiac CT

EXPERIMENTAL

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.

Radiation: Cardiac Computed Tomography

Interventions

Cardiac Computed Tomography RADIATION

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.

Cardiac CT

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (16)

• Karady J, Mayrhofer T, Januzzi JL, Udelson JE, Fleg JL, Merkely B, Lu MT, Peacock WF, Nagurney JT, Koenig W, Ferencik M, Hoffmann U. Agreement among high-sensitivity cardiac troponin assays and non-invasive testing, clinical outcomes, and quality-of-care outcomes based on the 2020 European Society of Cardiology Guidelines. Eur Heart J Acute Cardiovasc Care. 2024 Feb 9;13(1):15-23. doi: 10.1093/ehjacc/zuad146.

  PMID: 38001050 DERIVED

• 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.

  PMID: 33766254 DERIVED

• 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.

  PMID: 30405295 DERIVED

• 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.

  PMID: 30354493 DERIVED

• 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.

  PMID: 29138794 DERIVED

• 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.

  PMID: 28923845 DERIVED

• 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.

  PMID: 28487318 DERIVED

• 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.

  PMID: 27006119 DERIVED

• 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.

  PMID: 26762723 DERIVED

• 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.

  PMID: 26476506 DERIVED

• 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.

  PMID: 25819865 DERIVED

• Pursnani A, Chou ET, Zakroysky P, Deano 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):e002225. doi: 10.1161/CIRCIMAGING.114.002225. Epub 2015 Feb 20.

  PMID: 25710925 DERIVED

• 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.

  PMID: 25125300 DERIVED

• 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.

  PMID: 23685743 DERIVED

• 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.

  PMID: 22830462 DERIVED

• 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.

  PMID: 22424002 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction; Angina, Unstable; Emergencies

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Disease Attributes

Limitations and Caveats

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).

Results Point of Contact

• Title: Pearl Zakroysky
• Organization: Massachusetts Genderal Hospital Biostatistics Center

pzakroysky@partners.org

617 724 0309

Study Officials

• Udo Hoffmann, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiac Imaging

Study Record Dates

• First Submitted: January 7, 2010
• First Posted: March 10, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 7, 2014
• Results First Posted: May 7, 2014

Record last verified: 2014-04

Locations

US (1)