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

NCT01559467 | Completed

• 1 other identifier: NL37574.068.11 / METC 11-2-077
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Thirty-day clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications)

  30 days

• One-year clinical outcome (a composite of major adverse cardiac events [MACE] and major procedure related complications)

  One-year

• Quality of life

  One-year

• Cost-effectiveness

  After study completion, expected after 3 years

• Cardiogoniometry

  After study completion, expected after 3 years

Study Arms (3)

Routine clinical care plus early CMR

OTHER

Other: Cardiovascular Magnetic Resonance Imaging

Routine clinical care

NO INTERVENTION

Routine clinical care plus early CTA

OTHER

Other: Computed Tomography Angiography

Interventions

Cardiovascular Magnetic Resonance Imaging OTHER

Routine clinical care plus cardiovascular magnetic resonance imaging early in the diagnostic process

Routine clinical care plus early CMR

Computed Tomography Angiography OTHER

Routine clinical care plus computed tomography angiography early in the diagnostic process

Routine clinical care plus early CTA

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Dutch Heart Foundation: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6202 AZ, Netherlands

Location

Related Publications (14)

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  PMID: 19406338 BACKGROUND

• van Cauteren YJM, Smulders MW, Theunissen RALJ, Gerretsen SC, Adriaans BP, Bijvoet GP, Mingels AMA, van Kuijk SMJ, Schalla S, Crijns HJGM, Kim RJ, Wildberger JE, Heijman J, Bekkers SCAM. Cardiovascular magnetic resonance accurately detects obstructive coronary artery disease in suspected non-ST elevation myocardial infarction: a sub-analysis of the CARMENTA Trial. J Cardiovasc Magn Reson. 2021 Mar 22;23(1):40. doi: 10.1186/s12968-021-00723-6.

  PMID: 33752696 DERIVED

• Smulders MW, Kietselaer BLJH, Wildberger JE, Dagnelie PC, Brunner-La Rocca HP, Mingels AMA, van Cauteren YJM, Theunissen RALJ, Post MJ, Schalla S, van Kuijk SMJ, Das M, Kim RJ, Crijns HJGM, Bekkers SCAM. Initial Imaging-Guided Strategy Versus Routine Care in Patients With Non-ST-Segment Elevation Myocardial Infarction. J Am Coll Cardiol. 2019 Nov 19;74(20):2466-2477. doi: 10.1016/j.jacc.2019.09.027.

  PMID: 31727284 DERIVED

• 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.

  PMID: 24268210 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Harry J Crijns, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

• Joachim Wildberger, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: March 21, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2017
• Study Completion: June 19, 2017
• Last Updated: July 5, 2017

Record last verified: 2016-07

Locations

NL (1)