Resistance STEMI Study
Palabras clave
Abstracto
fechas
Verificado por última vez: | 06/30/2020 |
Primero enviado: | 02/01/2018 |
Inscripción estimada enviada: | 02/18/2018 |
Publicado por primera vez: | 02/19/2018 |
Última actualización enviada: | 07/13/2020 |
Última actualización publicada: | 07/15/2020 |
Fecha de inicio real del estudio: | 10/14/2018 |
Fecha estimada de finalización primaria: | 06/30/2019 |
Fecha estimada de finalización del estudio: | 06/30/2019 |
Condición o enfermedad
Intervención / tratamiento
Diagnostic Test: Study arm
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
Other: Study arm The study arm will undergo absolute flow and resistance measurements immediately after PPCI of the culprit artery | Diagnostic Test: Study arm Absolute flow and resistance measurements immediately after PPCI of the culprit vessel (in a STEMI setting) and repeated absolute flow and resistance measurements after 3-7 days |
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | All |
Acepta voluntarios saludables | si |
Criterios | Inclusion Criteria: - Age between 18 and 75 years - Presentation within 12 hours after the onset of complaints - Acute ST-elevation myocardial infarction with a total ST segment deviation ≥5 mm - Able to give and understand informed consent - Culprit lesion in a proximal or mid-segment of one of the major coronary arteries (diameter ≥2,5 mm), which is stented successfully - Stable condition after stenting - One or more additional lesions in one or more different coronary arteries, mandating FFR measurement +/- PPCI during the subacute phase Exclusion Criteria: - Age < 18 years or > 75 years - Cardiogenic shock or pre-shock, determined by the clinician - Patients with previous myocardial infarction in the culprit artery or with previous bypass surgery - Very tortuous or calcified coronary arteries - Long or complex PPCI - Severe concomitant disease or conditions with a life expectancy of less than 1 year - Inability to understand and give informed consent - Known myocardial diseases such as severe left ventricular hypertrophy or cardiomyopathy - Pregnancy - Severe conduction disturbances necessitating implantation of a temporary pacemaker - Contraindications for MRI (claustrophobia, ferromagnetic metal fragments in the body) |
Salir
Medidas de resultado primarias
1. Primary endpoint - changes in microvascular resistance [From date of randomization until the date of the second measurements (all within the first week after the index event).]
2. Co-primary endpoint - risk stratification [From date of randomization until the date of clinical follow-up at 1 year.]
Medidas de resultado secundarias
1. Secondary endpoint - left ventricular function [From date of randomization until the date of clinical follow-up at 1 year.]
2. Secondary outcome- Major adverse events [From date of randomization until the date of clinical follow-up at 1 year.]