Rule Out Myocardial Infarction by Computer Assisted Tomography

Myocardial Infarction Clinical Trial

— ROMICAT  

Official title:

Accuracy of Contrast Enhanced Multidetector Computed Tomography to Identify Cardiac Cause of Symptoms in Patients With Intermediate Likelihood of Acute Coronary Syndrome (ACS) - A Comparison to Standard Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00990262
• Other study ID #: 2003P000458
• Secondary ID: R01HL080053-01
• Status: Completed
• Phase: N/A
• First received: September 30, 2009
• Last updated: October 2, 2009
• Start date: May 2005
• Est. completion date: April 2009

Study information

• Verified date: October 2009
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The goal of this research is to determine noninvasively whether detection of coronary stenosis and plaque by multidetector computed tomography (MDCT) in patients with acute chest pain suspected of acute coronary syndrome (ACS) enhances triage, reduces cost and is cost effective. Among the 5.6 million patients with ACP presenting annually in emergency departments (ED) in the United States, a subgroup of two million patients is hospitalized despite normal initial cardiac biomarker tests and electrocardiogram (ECG). This subgroup is at low (20%) risk for ACS during the index hospitalization. Most (80-94%) patients with a diagnosis of ACS have a significant epicardial coronary artery stenosis ( >50% luminal narrowing). However, in -10% of patients non-stenotic coronary plaque triggers events, i.e. vasospasms, leading to myocardial ischemia. Since the absence of plaque excludes a coronary cause of chest pain, these patients could in theory be discharged earlier reducing unnecessary hospital admissions. Recent publications demonstrate high sensitivity and specificity of MDCT for the detection of significant coronary stenosis compared with coronary angiography and the detection of coronary plaque as validated with intravascular ultrasound. Using 64- slice MDCT we propose to study 400 patients with ACP, negative initial cardiac biomarkers and non-diagnostic ECG. We will analyze MDCT images for the presence of significant coronary artery stenosis and plaque and correlate the data with the clinical diagnosis of ACS (AHA guidelines) during the index hospitalization to determine the sensitivity and specificity. MDCT data, risk factors, and the results of standard diagnostic tests available at the time of MDCT will be used to generate a multivariate prediction function and derive a clinical decision rule. Based on this decision rule we will compare the diagnostic accuracies and cost effectiveness of competing strategies. We hypothesize that an MDCT- based diagnostic strategy will reduce the time to diagnosis of ACS, number of hospitalizations, and absolute cost of management of patients with acute chest pain compared to standard clinical care and is cost effective.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: April 2009
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with any episode > five minutes of chest pain being admitted to rule out acute coronary syndrome

Exclusion Criteria:

• Positive initial troponin or CK-MB tests

• Diagnostic ECG changes (ST- segment elevation or horizontal ST- segment depression in more than two contiguous leads)

• Unstable clinical condition (hemodynamically unstable, ventricular tachycardia, persistent chest pain despite adequate therapy)

• Creatinine Clearance <50 mL/min

• Known allergy to iodinated contrast agents

• Patients on metformin therapy unable or unwilling to discontinue therapy for 48 hours after CT scan procedure

• Known asthma, reactive airway disease

• Patients currently in atrial fibrillation

• Previous intolerance to beta blocker

• Patients that are referred for coronary angiography/PCI by their PCP or cardiologist.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina Pectoris
• Angina, Unstable
• Infarction
• Myocardial Infarction
• Unstable Angina Pectoris

Intervention

Radiation:
• Cardiac Computed Tomography
Localization of the heart position in a projectional topographic scan of the chest. Determination of contrast agent transit time: 10 ml contrast agent. CT coronary angiography: CT scan in spiral acquisition mode with 330 ms rotation time, 32 x 0.6 mm collimation, a pitch of 2.8 mm/rotation, tube voltage of 120 kVp, and maximum tube current of 850 mA. 80 ml of contrast agent, followed by 40 ml saline solution will be injected at a rate of 4 ml/s. The mean breath hold duration for this acquisition is approximately 13 seconds.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (7)

Hoffmann U, Bamberg F, Chae CU, Nichols JH, Rogers IS, Seneviratne SK, Truong QA, Cury RC, Abbara S, Shapiro MD, Moloo J, Butler J, Ferencik M, Lee H, Jang IK, Parry BA, Brown DF, Udelson JE, Achenbach S, Brady TJ, Nagurney JT. Coronary computed tomograph — View Citation

Hoffmann U, Nagurney JT, Moselewski F, Pena A, Ferencik M, Chae CU, Cury RC, Butler J, Abbara S, Brown DF, Manini A, Nichols JH, Achenbach S, Brady TJ. Coronary multidetector computed tomography in the assessment of patients with acute chest pain. Circula — View Citation

Lehman SJ, Schlett CL, Bamberg F, Nieman K, Abbara S, Hoffmann U. Appearance of acute and chronic coronary occlusions in contrast-enhanced cardiac computed tomography. JACC Cardiovasc Imaging. 2008 Nov;1(6):809-11. doi: 10.1016/j.jcmg.2008.07.016. Epub 2008 Nov 18. — View Citation

Mahabadi AA, Bamberg F, Toepker M, Schlett CL, Rogers IS, Nagurney JT, Brady TJ, Hoffmann U, Truong QA. Association of aortic valve calcification to the presence, extent, and composition of coronary artery plaque burden: from the Rule Out Myocardial Infar — View Citation

Manini AF, Dannemann N, Brown DF, Butler J, Bamberg F, Nagurney JT, Nichols JH, Hoffmann U; Rule-Out Myocardial Infarction using Coronary Artery Tomography (ROMICAT) Study Investigators. Limitations of risk score models in patients with acute chest pain. Am J Emerg Med. 2009 Jan;27(1):43-8. doi: 10.1016/j.ajem.2008.01.022. — View Citation

Truong QA, Bamberg F, Mahabadi AA, Toepker M, Lee H, Rogers IS, Seneviratne SK, Schlett CL, Brady TJ, Nagurney JT, Hoffmann U. Left atrial volume and index by multi-detector computed tomography: comprehensive analysis from predictors of enlargement to predictive value for acute coronary syndrome (ROMICAT study). Int J Cardiol. 2011 Jan 21;146(2):171-6. doi: 10.1016/j.ijcard.2009.06.029. Epub 2009 Jul 16. — View Citation

Truong QA, Toepker M, Mahabadi AA, Bamberg F, Rogers IS, Blankstein R, Brady TJ, Nagurney JT, Hoffmann U. Relation of left ventricular mass and concentric remodeling to extent of coronary artery disease by computed tomography in patients without left vent — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of CT derived features of coronary artery disease and LV function for ACS		ED presentation to hospital discharge	Yes
Secondary	Major adverse cardiac events (MACE) - defined as death, myocardial infarction or coronary revascularization		Follow up at 6 months and 2 year after index hospitalization	Yes