Typical Daily Experiences, Ischemia and Repolarization in Coronary Artery Disease

Typical Daily Emotions, Ischemia and Repolarization in Coronary Artery Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01531231

Enrollment

301

Registered

2012-02-10

Start date

2011-06-02

Completion date

2016-03-29

Last updated

2024-12-02

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

Conditions

Behavioral, Coronary Artery Disease

Keywords

heart disease, unstable angina, myocardial infarction, behavioral, cardiovascular, emotions

Brief summary

The purpose of this study is to examine the role of every day experiences as they relate to coronary artery disease (CAD).

Detailed description

CAD is the most common setting in which sudden cardiac death (SCD) occurs. SCD is the leading cause of death in the U.S. In this study we propose to test the following in patients with CAD: * Determine whether experiences assessed randomly throughout the day are associated with changes in the blood supply to your heart muscle as measured by electrical recordings from your chest. * Determine whether typical daily experiences are associated with changes in the recovery time portion of your heart beat cycle as measured by electrical recordings from your chest. * Determine whether changes in the recovery time portion of your heart beat cycle associated with typical daily experiences occur exclusively with changes in the blood supply to your heart muscle. * Determine whether typical daily experiences influences blood supply and recovery time based on the severity and presence of CAD (when comparing CAD patients to healthy subjects).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

KEY INCLUSION CRITERIA: LOW RISK CAD SUBJECTS, EJECTION FRACTION \>35% * Proficient in English * At least 21 years of age or older * Stable coronary artery disease * Willing to participant in 3 days of Holter monitor recordings and respond to surveys on a study provided smartphone KEY

Exclusion criteria

LOW RISK CAD SUBJECTS \- Presence of bundle branch block evident on ECG KEY INCLUSION CRITERIA: HIGH RISK CAD Subjects, Ejection Fraction \<35% * Proficient in English * 21 years of age or older * Have stable coronary artery disease with a documented previous myocardial infarction * Recent ECHO, MUGA or angiography (\< 5year old) reflecting a left-ventricular ejection fraction \<35% * Single or dual chamber ICD, with a back up rate of ventricular pacing at \< 45 bpm * Willing to wear a Holter monitor for 3 days and respond to surveys on a study provided smartphone KEY

Design outcomes

Primary

Measure	Time frame	Description
To obtain behavioral and cardiovascular data including 4-days collection of data as study participant engages in their daily activities.	4 days	To determine whether typical daily emotion is associated with myocardial ischemia and repolarization changes in patients with coronary artery disease, and then determine whether the association between repolarization changes and daily emotion is related to myocardial ischemia; whether daily emotion influences ischemia and repolarization differentially as a function of severity of coronary artery disease; whether the association between daily emotion and repolarization varies in healthy volunteers. Some of these outcomes are intertwined.

Countries

United States

Outcome results