Mental Stress and Myocardial Ischemia After MI: Sex Differences, Mechanisms and Prognosis

Mental Stress and Myocardial Ischemia After MI: Sex Differences, Mechanisms and Prognosis

Patrocinadores

Patrocinador principal: Emory University

Colaborador: National Heart, Lung, and Blood Institute (NHLBI)

Fuente Emory University
Resumen breve

The purpose of this study is to look at the link between emotional stress and heart disease in men and women. Taking part in this study involves one clinic visit, one week of at home monitoring, and follow up phone calls every 6 months for 3 years.

Descripción detallada

In the U.S. and globally, coronary heart disease (CHD) is the number one killer of women. Despite scientific advances, it is unclear whether the pathophysiology of CHD differs between women and men. The study of CHD in women has historically been centered on older women, however, women with early onset CHD are informative for the study of early risk factors and pathophysiology. Furthermore, young women with a myocardial infarction (MI) have emerged as a group in need of special study as this group has higher mortality compared with men of similar age despite less severe disease. These disparities remain unexplained and suggest sex differences in the pathophysiology, risk factors and prognostic factors of acute MI.

The psychosocial sphere is a largely neglected area for CHD prevention in women. Social and emotional exposures mostly beginning early in life (depression, early life adversities, poverty and posttraumatic stress symptoms) are more common in younger women with MI compared with men and community controls. In addition to being more prevalent, it is possible that emotional stress is a stronger risk factor in young women than other groups. A significant challenge, however, is to measure stress in a valid way.

Building on previous work, the current project will clarify sex differences in pathways of risk linking emotional stress to mental stress-induced myocardial ischemia (MSI) and cardiovascular outcomes in young post-MI patients. Within 8 months of MI, 300 patients ≤60 years of age (at the time of the MI), 50% women, will be tested in the lab with a stress challenge to asses MSI using an established protocol with myocardial perfusion imaging. Participants will be monitored at home for 1 week, and then followed for clinical events for 3 years.

Estado general Recruiting
Fecha de inicio February 28, 2020
Fecha de Terminación June 2024
Fecha de finalización primaria June 2024
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Cardiovascular Events 3 Years
Resultado secundario
Medida Periodo de tiempo
Myocardial Infarction or Cardiovascular Death 3 Years
Cardiovascular Death 3 Years
Total Mortality 3 Years
Cardiovascular Events Excluding Heart Failure 3 Years
Inscripción 300
Condición
Intervención

Tipo de intervención: Other

Nombre de intervención: Stress Challenge

Descripción: The stress challenge will assess how different parts of the body react to stress. Participants will be given no specific details about the contents of the test before administration.

Etiqueta de grupo de brazo: Young Participants with Prior MI

Elegibilidad

Criterios:

Inclusion Criteria:

- History of documented MI within the past 8 months

- Age ≤60 at the time of MI

Exclusion Criteria:

- History of unstable angina, MI, or decompensated heart failure in past month

- Patients deemed to be unsafe to hold anti-ischemic medications before testing (it is standard protocol to hold these meds before imaging studies)

- Systolic blood pressure (SBP) >170 mm Hg or diastolic blood pressure (DBP) >100 mm Hg on the day of the test

- Alcohol or substance abuse (past year), or severe psychiatric disorder other than major depression

- Other serious medical disorder that may interfere with the study results

- Postmenopausal hormone therapy (past 3 months)

- Current psychotropic medications (past month) except anti-depressants

- Pregnancy or breast feeding (all women will receive a pregnancy test)

- Severe aortic stenosis

- Weight ≥ 350 pounds and/or body mass index (BMI) of 40 or greater (weIght limit of the SPECT imaging table)

Género: All

Edad mínima: 18 Years

Edad máxima: 60 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Viola Vaccarino, MD, PhD Principal Investigator Emory University
Contacto general

Apellido: Lucy Shallenberger

Teléfono: 404-712-8267

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto:
Emory University Hospital | Atlanta, Georgia, 30322, United States Recruiting Lucy Shallenberger 404-712-8267 [email protected]
Grady Health System | Atlanta, Georgia, 30322, United States Recruiting Lucy Shallenberger 404-712-8267 [email protected]
The Emory Clinic | Atlanta, Georgia, 30322, United States Recruiting Lucy Shallenberger 404-712-8267 [email protected]
Ubicacion Paises

United States

Fecha de verificación

July 2020

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Emory University

Nombre completo del investigador: Viola Vaccarino MD/PhD

Título del investigador: Professor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 1
Grupo de brazo

Etiqueta: Young Participants with Prior MI

Tipo: Other

Descripción: Participants aged 60 or less who experienced a MI within the last 8 months will undergo a stress challenge to assess MSI and will then be followed for 3 years.

Acrónimo MIMS3
Datos del paciente No
Información de diseño del estudio

Asignación: N/A

Modelo de intervención: Single Group Assignment

Propósito primario: Basic Science

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov