A Study to Evaluate Ischemia in Women to Reduce Non-obstructive CAD Events

Overview

Información sobre este estudio

The purpose of this trial is to determine whether aggressive medication treatment to modify risk factors in women with coronary arteries showing no severe obstruction but with cardiac symptoms (i.e., chest pain) will reduce their likelihood of dying, having a heart attack, stroke or being hospitalized. 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Signs and symptoms of suspected ischemia prompting referral for further evaluation by cardiac catheterization, or coronary angiogram or coronary CT angiogram within 5 years from consent.
  • Willing to provide written informed consent.
  • Age ≥ 18 years old.
  • Non-obstructive CAD defined as 0 to 49% diameter reduction of a major epicardial vessel or a FFR > 0.80.

Exclusion Criteria:

  • History of noncompliance (with medical therapy, protocol, or follow-up).
  • History of non-ischemic dilated or hypertrophic cardiomyopathy.
  • Documented ACS within previous 30 days.
  • LVEF < 40%, NYHA HF class III-IV, or hospitalization for HFrEF within 180 days.
  • Stroke within previous 180 days or intracranial hemorrhage at any time.
  • End-stage renal disease, on dialysis, or estimated glomerular filtration rate (eGFR) < 30 ml/min.
  • Severe valvular disease or likely to require surgery/TVAR within 3 years.
  • Life expectancy < 3 years due to non-cardiovascular comorbidity.
  • Enrolled in a competing clinical trial.
  • Prior intolerance to both an ACE-I and ARB.
  • If intolerant to a statin unless taking a PCSK9 as a statin replacement by their clinical provider.
  • Pregnancy (If they have not gone through menopause, had a hysterectomy, oophorectomy, or sterilization such as tubal ligation procedure, all pre-menopausal females must have negative urine pregnancy test if randomized to IMT before study drugs are prescribed).

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Amy Pollak, M.D.

Abierto para la inscripción

Contact information:

Erika Douglass M.P.H.

(904) 953-6595

Douglass.Erika@mayo.edu

More information

Publicaciones

Publications are currently not available