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(Non-)ST-elevation myocardial infarction and Multivessel coronary Artery disease: coronary Resistance guided multivessel Treatment.

(Non-)ST-elevation myocardial infarction and Multivessel coronary Artery disease: coronary Resistance guided multivessel Treatment. - SMART

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34491
Enrollment
300
Registered
2011-03-18
Start date
2010-08-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

coronary artery disease

Interventions

In case of a postive exercise test, PCI of the laesion of interest will only be performed when both CFR and FFR are indicative for ischemia.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with a second and/or third coronary lesion in the presence of a successfully treated acute coronary occlusion of another coronary vessel are amendable for inclusion.

Exclusion criteria

Exclusion criteria: - Age under 18 and above 80 yrs. - Cardiogenic shock - Anatomical or anticipated problems for complete percutaneous coronary revascularization i.e. diffuse disease, chronic total occlusion. - Prior or indication for coronary artery bypass grafting (CABG) - Presence of a significant left main coronary artery stenosis (> 50% diameter stenosis) - Renal impairment (e.g. serum creatinine level of more than 130 *mol/L) -Unable to exercise -Ventricular arrhythmias, i.e. sustained ventricular tachycardia (VT) or ventricular fibrillation (VF), more than 48 hours after primary PCI -Severe valvular heart disease requiring cardiac surgery within twelve months -Serious known concomitant disease with a life expectancy of less than one year -Factors making follow-up difficult (e.g. not fixed home or address, psychological instability, drugs or alcohol addiction, etc.). -Current participation in another trial.

Design outcomes

Primary

MeasureTime frame
A composite of cardiac death, acute myocardial infarction, recurrent revascularization guided by objective evidence of myocardial ischemia at 12 months.

Secondary

MeasureTime frame
A composite of all-cause death, myocardial infarction, stroke, severe vascular events, recurrent revascularization guided by objective evidence of myocardial ischemia at 12 months.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)