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

Coronary Artery Disease Clinical Trial

— CARMENTA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559467
• Other study ID #: NL37574.068.11 / METC 11-2-077
• Status: Completed
• Phase: N/A
• First received: March 12, 2012
• Last updated: July 3, 2017
• Start date: April 2012
• Est. completion date: June 19, 2017

Study information

• Verified date: July 2016
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 19, 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Ischemia
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Other:
• Cardiovascular Magnetic Resonance Imaging
Routine clinical care plus cardiovascular magnetic resonance imaging early in the diagnostic process
• Computed Tomography Angiography
Routine clinical care plus computed tomography angiography early in the diagnostic process

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Dutch Heart Foundation

Country where clinical trial is conducted

Netherlands, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. Update in: Cochrane Database Syst Rev. 2016;(5):CD004815. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of patients with at least one invasive coronary angiography during initial admission		During initial hospital admission, an expected average of 7 days
Secondary	Thirty-day clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications)		30 days
Secondary	One-year clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications)		One-year
Secondary	Quality of life		One-year
Secondary	Cost-effectiveness	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.	After study completion, expected after 3 years
Secondary	Cardiogoniometry	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	After study completion, expected after 3 years