To investigate in patients with suspected non-ST elevation MI meeting the *observe* criteria and who are scheduled for ICA:1. The diagnostic accuracy of CMR to detect obstructive CAD using ICA as gold standard2. The diagnostic accuracy of CT to…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the sensitivity of CMR to detect obstructive CAD using
ICA as gold standard in patients with suspected NSTEMI meeting the *observe*
criteria and who are scheduled for ICA.
Secondary outcome
• The diagnostic accuracy of CT to detect obstructive CAD using ICA as gold
standard
• The diagnostic accuracy of CMR, CT and ICA to detect a non-ST elevation acute
coronary syndrome and differentiate non coronary causes for elevated troponin
• The true incidence of coronary, non-coronary and extracardiac pathology by a
comprehensive (non-)invasive pathway
• The association between CMR, CT and ICA findings, and MACE, a composite of
MACE, and major non cardiac adverse events after 30 days and one year
• The hypothetical cost-effectiveness of an early discharge strategy based on a
CMR or CT first approach versus a routine invasive strategy
• The clinical benefit of CMR and/or CT when added to the diagnostic process in
finding the diagnosis and patient management
• The ability of identifying the culprit coronary artery with CMR, CT and ICA
• To correlation of quantitative perfusion methods: CMR perfusion vs CT
perfusion (rest) vs CT-FFR vs intracoronary ICA measurements
• To assess the clinical value of CT and/or CMR (eg. change in clinical
diagnosis, indication for revascularization, patient management [medication])
Background summary
Evaluating patients with acute chest pain, elevated high-sensitive cardiac
troponin (hs-cTn) levels and inconclusive electrocardiogram (ECG), i.e.
suspected non-ST elevation myocardial infarction (MI), is a daily challenge.
Although contemporary hs-cTn assay-based algorithms have greatly facilitated
clinical decision-making, still one-quarter of patients is categorized as
*observe* group and in whom a diagnosis initially remains unknown. Although
routinely treated as acute MI with referral to invasive coronary angiography
(ICA), up to one-third of patients classified as *observe* does not have
obstructive coronary artery disease (CAD). Follow-up cardiovascular magnetic
resonance imaging (CMR) has been shown to be a very useful diagnostic tool in
this setting but is not part of routine clinical care in every patient.
Similarly, cardiac computed tomography (CT) is accurate in detecting CAD, but
its role in patients categorized as *observe* remains unknown.
Study objective
To investigate in patients with suspected non-ST elevation MI meeting the
*observe* criteria and who are scheduled for ICA:
1. The diagnostic accuracy of CMR to detect obstructive CAD using ICA as gold
standard
2. The diagnostic accuracy of CT to detect obstructive CAD using ICA as gold
standard
3. The diagnostic accuracy of CMR, CT and ICA to detect a non-ST elevation
acute coronary syndrome and differentiate non coronary causes for elevated
troponin
4. The true incidence of coronary, non-coronary and extracardiac pathology by a
comprehensive (non-)invasive pathway
5. The association between CMR, CT and ICA findings, and MACE, a composite of
MACE, and major non cardiac adverse events after 30 days and one year
6. To assess the hypothetical cost-effectiveness of an early discharge strategy
based on a CMR or CT first approach versus a routine invasive approach
7. To compare quantitative perfusion methods: CMR perfusion vs CT perfusion
(rest) vs CT-FFR vs intracoronary ICA measurements
8. To identify the culprit coronary artery in patients and compare results
between CMR, CT and ICA
9. To assess the clinical value of CT and/or CMR (eg. change in clinical
diagnosis, indication for revascularization, patient management [medication])
Study design
In this prospective, observational two-center study in The Netherlands (MUMC+
and Radboudumc), 127 consecutive patients with acute chest pain, an
inconclusive ECG and hs-cTnT levels meeting the observe criteria and scheduled
for ICA, will be investigated. Patients will undergo a comprehensive CMR and CT
examination prior to ICA and will be followed-up for one year. After completion
of follow-up, an independent clinical diagnosis committee will adjudicate a
final diagnosis based on all available data.
Study burden and risks
CMR and CT are accepted and safe imaging modalities in patients with
(suspected) non-ST-elevation myocardial infarction. The treating physician and
patient will receive the CMR and CT results immediately after the routine
diagnostic work-up, which may be used to improve patient treatment. Additional
CT examination with a mean/median estimated additional radiation exposure of <=
10 mSv will be performed during hospital admission.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
• Acute onset chest pain (or angina pectoris equivalent) suspected of
non-ST-elevation myocardial infarction (NSTEMI)
• Hs-cTnT levels meeting the *observe* criteria (defined in the 2020 ESC
Guidelines)
• Hospital admission and scheduling for ICA (based on clinical judgement)
• Age between 18 years - 85 years old
• Written informed consent
Exclusion criteria
• Symptoms highly suggestive of non-cardiac origin at presentation (as judged by the cardiac ED physician/cardiologist) or highly suggestive of AAD, PE, or acute peri-myocarditis (unless this has been ruled out using additional diagnostic testing) • Suspected type II MI: e.g. secondary to anemia (<5.6 mmol/L), untreated hyperthyroidism, severe hypertension (>200/110 mmHg), moderate or severe mitral/aortic valve stenosis by latest echocardiography • Atrial fibrillation or ongoing tachycardia (>=100/bpm) • Safety: indication for urgent or immediate ICA: e.g. hemodynamic unstable patients, life threatening arrhythmias, ST-elevation MI, heart failure requiring intravenously medication, refractory angina or on-going severe ischemia • Logistics: Inability to organize CMR and CT early after admission (especially for patients admitted on Friday evenings/nights • History: prior CABG, recent PCI (<6 months), recent myocardial infarction (<6 months), or known CAD not suitable for further interventions (PCI or CABG) • Pregnancy or breast feeding women • Life expectancy <1 year (malignancy, etc.) • Contraindications to CMR or CT: o Metallic implant (vascular clip, neuro-stimulator, cochlear implant) o Pacemaker or implantable cardiac defibrillator (ICD) o Claustrophobia o Body weight >130 kg or BMI > 35 or body habitus that does not fit into the gantry o Renal failure (estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1,73m2) o Known severe allergy to gadolinium or iodine contrast agents (patient with mild allergy is eligible for inclusion when pre-medication according to hospital guidelines can be administered) • Contraindications to adenosine: o High degree atrio-ventricular block (2nd or 3rd degree) o Severe bronchial asthma or recent exacerbation o Chronic obstructive pulmonary disease GOLD * III o Concomitant use of Dipyridamole (Persantin®) o Long QT syndrome (congenital) o Unable to refrain from caffeine >=12 hours prior to the examination
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04140019 |
| CCMO | NL65125.068.18 |