The Supplementary Role of Non-invasive Imaging to Routine Clinical Practice in Suspected Non-ST-elevation Myocardial Infarction - Full Text View

Purpose

Approximately half of patients with acute chest pain, a very common reason for emergency department visits worldwide, have a cardiac cause. Two-thirds of patients with a cardiac cause are eventually diagnosed with a so-called non-ST-elevation myocardial infarction. The diagnosis of non-ST-elevation myocardial infarction is based on a combination of symptoms, electrocardiographic changes, and increased serum cardiac specific biomarkers (high-sensitive troponin T). Although being very sensitive of myocardial injury, increased high-sensitive troponin T levels are not specific for myocardial infarction. Invasive coronary angiography is still the reference standard for coronary imaging in suspected non-ST-elevation myocardial infarction. This study investigates whether non-invasive imaging early in the diagnostic process (computed tomography angiography (CTA) or cardiovascular magnetic resonance imaging (CMR)) can prevent unnecessary invasive coronary angiography. For this, patients will be randomly assigned to either one of three strategies: 1) routine clinical care and computed tomography angiography early in the diagnostic process, 2) routine clinical care and cardiovascular magnetic resonance imaging early in the diagnostic process, or 3) routine clinical care without non-invasive imaging early in the diagnostic process.

Condition	Intervention
Chest Pain Myocardial Infarction Acute Coronary Syndrome Coronary Artery Disease Myocardial Ischemia	Other: Cardiovascular Magnetic Resonance Imaging Other: Computed Tomography Angiography


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	The Supplementary Role of Cardiovascular Magnetic Resonance Imaging and Computed Tomography Angiography to Routine Clinical Practice in Suspected Non-ST Elevation Myocardial Infarction - A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Chest Pain Coronary Artery Disease Diagnostic Imaging Heart Attack MRI Scans

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:

Total number of patients with at least one invasive coronary angiography during initial admission [ Time Frame: During initial hospital admission, an expected average of 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Thirty-day clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
One-year clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications) [ Time Frame: One-year ] [ Designated as safety issue: Yes ]
Quality of life [ Time Frame: One-year ] [ Designated as safety issue: No ]
Cost-effectiveness [ Time Frame: After study completion, expected after 3 years ] [ Designated as safety issue: No ]
The economic evaluation will be a cost-effectiveness analysis, with quality-adjusted life years (QALYs) as outcome measure. Effects will be calculated in terms of QALYs. To investigate the cost-effectiveness of the three strategies, incremental cost-effectiveness ratios (ICERs) will be calculated. Cost-effectiveness acceptability curves (CEACs) are derived in order to show the probability of each strategy being the optimal choice, for a range of possible maximum values a decision maker is willing to pay for a QALY.
Cardiogoniometry [ Time Frame: After study completion, expected after 3 years ] [ Designated as safety issue: No ]
A retrospective analysis will be performed to investigate whether CGM performed on the cardiac emergency department can differentiate between a coronary and non-coronary etiology in suspected NSTEMI


Estimated Enrollment:	300
Study Start Date:	April 2012
Estimated Study Completion Date:	April 2015
Estimated Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Routine clinical care plus early CMR	Other: Cardiovascular Magnetic Resonance Imaging Routine clinical care plus cardiovascular magnetic resonance imaging early in the diagnostic process
No Intervention: Routine clinical care
Routine clinical care plus early CTA	Other: Computed Tomography Angiography Routine clinical care plus computed tomography angiography early in the diagnostic process

Eligibility


Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Prolonged symptoms suspected of cardiac origin (angina pectoris or angina equivalent), and presentation on the cardiac emergency department <24 hours after symptom onset
- Increased levels of high-sensitive Troponin-T (>14ng/L)
- Age >18 years and <85 years
- Willing and capable to give written informed consent
- Written informed consent

Exclusion Criteria:

Ongoing severe ischemia requiring immediate invasive coronary angiography
Shock (mean arterial pressure < 60 mmHg) or severe heart failure (Killip Class ≥ III)
ST-elevation myocardial infarction (ST-elevation in 2 contiguous leads: ≥0.2mV in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads or new left bundle branch block)
Chest pain highly suggestive of non-cardiac origin:
- Acute aortic dissection
- Acute pulmonary embolism (high risk patient defined as Wells score >6)
- Musculoskeletal or gastro-intestinal pain
- Other (pneumothorax, pneumonia, rib fracture, etc.)
Previously known coronary artery disease, defined as:
- Any non-invasive diagnostic imaging test positive for coronary artery disease
- Coronary stenosis >50% on any previous invasive coronary angiography or computed tomography angiography
- Documented previous myocardial infarction
- Documented previous coronary artery revascularization
- Known cardiomyopathy
Pregnancy
Life threatening arrhythmia on the cardiac emergency department or prior to presentation
Tachycardia (≥100/bpm)
Atrial fibrillation
Angina pectoris secondary to anemia (<5.6 mmol/L), untreated hyperthyroidism, aortic valve stenosis (aortic valve area ≤ 1.5 cm2), or severe hypertension (>200/110 mmHg)
Life expectancy <1 year (malignancy, etc.)
Contraindications to cardiovascular magnetic resonance imaging: metallic implant (vascular clip, neuro-stimulator, cochlear implant), pacemaker or implantable cardiac defibrillator, claustrophobia

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559467

Contacts


Contact: Martijn W Smulders, MD	+31-43-3875098	martijn.smulders@mumc.nl
Contact: Sebastiaan C Bekkers, MD, PhD	+31-43-3875098	s.bekkers@mumc.nl

Locations


Netherlands
Maastricht University Medical Center	Recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Contact: Sebastiaan C Bekkers, MD, PhD +31-43-3875098 s.bekkers@mumc.nl
Contact: Bas Kietselaer, MD, PhD +31-43-3875093 b.kietselaer@mumc.nl
Principal Investigator: Harry J Crijns, MD, PhD
Principal Investigator: Joachim Wildberger, MD, PhD
Sub-Investigator: Sebastiaan C Bekkers, MD, PhD
Sub-Investigator: Bas Kietselaer, MD, PhD

Sponsors and Collaborators

Maastricht University Medical Center

Dutch Heart Foundation

Investigators


Principal Investigator:	Harry J Crijns, MD, PhD	Maastricht University Medical Center
Principal Investigator:	Joachim Wildberger, MD, PhD	Maastricht University Medical Center

More Information

Publications:

Hamm CW, Goldmann BU, Heeschen C, Kreymann G, Berger J, Meinertz T. Emergency room triage of patients with acute chest pain by means of rapid testing for cardiac troponin T or troponin I. N Engl J Med. 1997 Dec 4;337(23):1648-53.

Reichlin T, Hochholzer W, Bassetti S, Steuer S, Stelzig C, Hartwiger S, Biedert S, Schaub N, Buerge C, Potocki M, Noveanu M, Breidthardt T, Twerenbold R, Winkler K, Bingisser R, Mueller C. Early diagnosis of myocardial infarction with sensitive cardiac troponin assays. N Engl J Med. 2009 Aug 27;361(9):858-67. doi: 10.1056/NEJMoa0900428.

Kim HW, Farzaneh-Far A, Kim RJ. Cardiovascular magnetic resonance in patients with myocardial infarction: current and emerging applications. J Am Coll Cardiol. 2009 Dec 29;55(1):1-16. doi: 10.1016/j.jacc.2009.06.059. Review.

Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS, Smith SC Jr; 2011 WRITING GROUP MEMBERS; ACCF/AHA TASK FORCE MEMBERS. 2011 ACCF/AHA Focused Update Incorporated Into the ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011 May 10;123(18):e426-579. doi: 10.1161/CIR.0b013e318212bb8b. Epub 2011 Mar 28. Erratum in: Circulation. 2011 Jun 7;123(22):e627.

Hoenig MR, Aroney CN, Scott IA. Early invasive versus conservative strategies for unstable angina and non-ST elevation myocardial infarction in the stent era. Cochrane Database Syst Rev. 2010 Mar 17;(3):CD004815. doi: 10.1002/14651858.CD004815.pub3. Review.

Ricciardi MJ, Wu E, Davidson CJ, Choi KM, Klocke FJ, Bonow RO, Judd RM, Kim RJ. Visualization of discrete microinfarction after percutaneous coronary intervention associated with mild creatine kinase-MB elevation. Circulation. 2001 Jun 12;103(23):2780-3.

Kwong RY, Schussheim AE, Rekhraj S, Aletras AH, Geller N, Davis J, Christian TF, Balaban RS, Arai AE. Detecting acute coronary syndrome in the emergency department with cardiac magnetic resonance imaging. Circulation. 2003 Feb 4;107(4):531-7.

Leurent G, Langella B, Fougerou C, Lentz PA, Larralde A, Bedossa M, Boulmier D, Le Breton H. Diagnostic contributions of cardiac magnetic resonance imaging in patients presenting with elevated troponin, acute chest pain syndrome and unobstructed coronary arteries. Arch Cardiovasc Dis. 2011 Mar;104(3):161-70. doi: 10.1016/j.acvd.2011.01.005. Epub 2011 Apr 2.

Meijboom WB, Mollet NR, Van Mieghem CA, Weustink AC, Pugliese F, van Pelt N, Cademartiri F, Vourvouri E, de Jaegere P, Krestin GP, de Feyter PJ. 64-Slice CT coronary angiography in patients with non-ST elevation acute coronary syndrome. Heart. 2007 Nov;93(11):1386-92. Epub 2007 Mar 7.

Vanhoenacker PK, Decramer I, Bladt O, Sarno G, Bevernage C, Wijns W. Detection of non-ST-elevation myocardial infarction and unstable angina in the acute setting: meta-analysis of diagnostic performance of multi-detector computed tomographic angiography. BMC Cardiovasc Disord. 2007 Dec 19;7:39. Review.

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 tomography angiography for early triage of patients with acute chest pain: the ROMICAT (Rule Out Myocardial Infarction using Computer Assisted Tomography) trial. J Am Coll Cardiol. 2009 May 5;53(18):1642-50. doi: 10.1016/j.jacc.2009.01.052.

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

Smulders MW, Kietselaer BL, Das M, Wildberger JE, Crijns HJ, Veenstra LF, Brunner-La Rocca HP, van Dieijen-Visser MP, Mingels AM, Dagnelie PC, Post MJ, Gorgels AP, van Asselt AD, Vogel G, Schalla S, Kim RJ, Bekkers SC. The role of cardiovascular magnetic resonance imaging and computed tomography angiography in suspected non-ST-elevation myocardial infarction patients: design and rationale of the CARdiovascular Magnetic rEsoNance imaging and computed Tomography Angiography (CARMENTA) trial. Am Heart J. 2013 Dec;166(6):968-75. doi: 10.1016/j.ahj.2013.09.012. Epub 2013 Oct 23.


Responsible Party:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT01559467 History of Changes
Other Study ID Numbers:	NL37574.068.11 / METC 11-2-077
Study First Received:	March 12, 2012
Last Updated:	May 2, 2013
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:


Myocardial infarction Randomized Controlled Trial Magnetic Resonance Imaging Coronary Angiography Tomography, X-Ray Computed	Mortality Complications Quality of Life Cost-Benefit Analysis

Additional relevant MeSH terms:


Acute Coronary Syndrome Coronary Artery Disease Infarction Myocardial Infarction Myocardial Ischemia Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases	Chest Pain Coronary Disease Heart Diseases Ischemia Necrosis Pain Pathologic Processes Signs and Symptoms Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015

The Supplementary Role of Non-invasive Imaging to Routine Clinical Practice in Suspected Non-ST-elevation Myocardial Infarction (CARMENTA)