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.

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. - Non-invasive imaging in suspected NSTEMI CARMENTA trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43969

Enrollment

360

Registered

2012-02-27

Start date

2012-04-11

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-ST elevation myocardial infarction - Heart attack

Interventions

Three arms: - Routine clinical care - CTA guided strategy - CMR guided strategy

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: *Prolonged symptoms suspected of cardiac origin (angina pectoris or angina equivalent), and presentation on the cardiac ED

Exclusion criteria

Exclusion criteria: *Ongoing severe ischemia requiring immediate ICA (at discretion of cardiac ED physician/cardiologist) *Shock (mean arterial pressure 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 (200/110 mmHg) *Life expectancy 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 outcomes

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Primary

Measure	Time frame
Total number of patient with at least one ICA during the initial admission	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)