Primairy objectives:1.To investigate whether a non-invasive imaging guided strategy (either CTA or CMR) early in the diagnostic process reduces the number of patients with at least one ICA during the initial admission as compared to routine clinical…
ID
Source
Brief title
CARMENTA trial
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Total number of patient with at least one ICA during the initial admission
Secondary outcome
Secondary study parameters/outcome
*Thirty-day clinical outcome (MACE)
*Composite of one-year clinical outcome (MACE) and major adverse events
*Time to final diagnosis (in days)
*Number of CCA that can be identified in patients with a final diagnosis of MI
*Quality of life
*Cost-effectiveness
Tertiary study parameters/outcome:
*The total number of patients with a coronary etiology correctly identified by
cardiogoniometry
*Preferences of patients for attributes of CTA and CMR
Background summary
Accurate and early diagnosis followed by appropriate therapy in patients with
non-ST segment elevation myocardial infarction (NSTEMI) improves outcome. The
diagnosis in NSTEMI heavily relies on the result of cardiac biomarker testing
(i.e. troponins). Although very sensitive and specific for myocardial injury,
troponins are not specific as to the cause of injury. Invasive coronary
angiography (ICA) is still the reference standard for coronary imaging in
suspected NSTEMI. Because patients may have insignificant coronary stenosis and
overlapping disorders other than NSTEMI, a substantial number of unnecessary
ICA are performed. Furthermore, guidelines recommend treatment of the culprit
coronary artery (CCA) in NSTEMI, but a clear CCA cannot be identified in a
substantial number of patients. Both cardiovascular magnetic resonance imaging
(CMR) and computed tomography angiography (CTA) hold promise as additional
tests to differentiate between a coronary and a non-coronary etiology in
suspected NSTEMI, thereby preventing unnecessary ICA, and in addition, may help
to identify the CCA. This study investigates whether either CTA or CMR early in
the diagnostic process reduces the number of patients with at least one ICA
during initial admission and improves identification of the CCA in NSTEMI as
compared to routine clinical care. This strategy may improve clinical outcome
and be cost-effective.
Study objective
Primairy objectives:
1.To investigate whether a non-invasive imaging guided strategy (either CTA or
CMR) early in the diagnostic process reduces the number of patients with at
least one ICA during the initial admission as compared to routine clinical
management in patients with acute chest pain and elevated hs-TnT levels (i.e.
suspected NSTEMI).
Secondary objectives:
To investigate whether a non-invasive imaging guided strategy (either CTA or
CMR) early in the diagnostic process as compared to routine clinical management
in suspected NSTEMI:
2. has no adverse effect on thirty-day clinical outcome (MACE);
3. has a superior effect on a composite endpoint of one-year clinical outcome
(MACE) and major (non-cardiac) adverse events (complications);
4. reduces the time to final diagnosis;
5. increases the number of CCA that can be identified in patients with a final
diagnosis of MI (patients with true NSTEMI);
6. improves quality of life;
7. is cost-effective.
Tertiary objectives:
8. To retrospectively investigate whether cardiogoniometry (CGM Enverdis® GmbH)
as an inexpensive, easily applicable and non-invasive tool, is able to
differentiate between a coronary and non-coronary etiology in suspected NSTEMI.
9. To study patients' preferences regarding attributes of a non-invasive
imaging guided strategy (CTA and CMR) early in the diagnostic process.
Study design
In this prospective, single center, randomized controlled clinical trial, three
hundred consecutive patients visiting the cardiac emergency department (ED)
with suspected NSTEMI (elevated hs-TnT *0.014*g/L)) will be randomized to
either one of three strategies: CMR or CTA early in the diagnostic process or
routine clinical management (without early non-invasive imaging). A stratified
randomization method will be used to equally distribute patients based on
hs-TnT levels. In the CMR and CTA groups, the results of non-invasive imaging
will guide further clinical management. An independent expert panel will assign
a final diagnosis based on all available clinical data and on a separate
occasion identify the CCA based on ICA.
Intervention
Three arms:
- Routine clinical care
- CTA guided strategy
- CMR guided strategy
Study burden and risks
Both CMR and CTA are accepted and safe imaging modalities in NSTEMI patients.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
*Prolonged symptoms suspected of cardiac origin (angina pectoris or angina
equivalent), and presentation on the cardiac ED <24 hours after symptom onset
*Increased highly sensitive troponin-T level (hs-TnT *0.014*g/L) (initial blood sample at presentation or a second sample *3 hours after presentation)
*Age 18 years * 85 years
*Willing and capable to give written informed consent
*Written informed consent
Exclusion criteria
*Ongoing severe ischemia requiring immediate ICA (at discretion of cardiac ED
physician/cardiologist)
*Shock (mean arterial pressure < 60 mmHg) or severe heart failure (Killip Class * III)
*STEMI (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 (as judged by the cardiac ED
physician/cardiologist):
o Acute aortic dissection
o Acute pulmonary embolism (high risk patient defined as Wells score >6)
o Musculoskeletal or gastro-intestinal pain
o Other (pneumothorax, pneumonia, rib fracture, etc.)
*Previously known coronary artery disease (CAD), defined as:
o Any non-invasive diagnostic imaging test positive for CAD (perfusion defects, and/or stress induced wall motion abnormalities)
o Coronary stenosis >50% on any previous ICA or CTA
o Documented previous myocardial infarction
o Documented previous coronary artery revascularization (PCI and/or CABG)
*Known cardiomyopathy (dilated, hypertrophic, infiltrative, etc.)
*Pregnancy
*Life threatening arrhythmia on the cardiac ED or prior to presentation
(sustained ventricular tachycardia, repetitive non-sustained ventricular tachycardia, ventricular
fibrillation, sino-artial or atrio-ventricular block)
*Atrial fibrillation
*Tachycardia (*100/bpm) induced angina pectoris
*Angina pectoris secondary to anemia (<5.6 mmol/L), untreated hyperthyroidism, aortic valve stenosis (AVA * 1.5 cm2), or severe hypertension (>200/110 mmHg)
*Life expectancy <1 year (malignancy, etc.);*Contraindications to CMR:
ODIN protocol: *Uitvoering van MRI onderzoek bij patiënten met een cardiaal implanteerbaar elektronisch device (CIED), waaronder een pacemaker en ICD*
ODIN protocol: *Voorbereiding klinische patiënten voor MRI onderzoek*
o Metallic implant (vascular clip, neuro-stimulator, cochlear implant)
o Pacemaker or implantable cardiac defibrillator (ICD)
o Claustrophobia
o Body weight >130 kg;*Contraindication to CMR or CTA contrast agent (Gadolinium or Iodine):
ODIN protocol: *Voorbereiding bij contrastonderzoeken of -interventies met intravasculair gebruik van jodiumhoudende contrastmiddelen; voorkomen van contrastnefropathie, CIN, hydratieschema*
o Renal failure (estimated GFR *30 mL/min/1,73m2) / chronic renal failure stage 4-5 (details for
CTA arm in appendix D: detailed CTA protocol)
o Known severe contrast allergy (patient with mild allergy is eligible for inclusion
when pre-medication according to hospital guidelines can be administered);*Contraindication to adenosine:
o High degree atrio-ventricular block (2nd or 3rd degree)
o Severe asthma bronchiale
o Chronic obstructive pulmonary disease Gold * III
o Concomitant use of dipyridamole (Persantin)
o Long QT syndrome (congenital)
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 | NCT01559467 |
| CCMO | NL37574.068.11 |