Typical Daily Experiences, Ischemia and Repolarization in Coronary Artery Disease

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

Detailed Description
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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).

Official Title
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Typical Daily Emotions, Ischemia and Repolarization in Coronary Artery Disease

Conditions
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Coronary Artery Disease, Behavioral

Participation Criteria
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Eligibility Criteria
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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 EXCLUSION CRITERIA: HIGH RISK CAD, Ejection Fraction <35% An implanted cardiac resynchronization pacemaker with ICD (CRT-D) Heart rhythm artificially continuously paced Presence of a bundle branch block evident on any ECG KEY INCLUSION CRITERIA: OLDER HEALTHY COMPARISON Proficient in English 51 years of age or older No history and evidence of ischemic heart disease Normal screening ECG without evidence for rhythm abnormalities, conduction abnormalities, hypertrophy, or other pathologies Age matched within 5 years to CAD patients Negative treadmill/bicycle exercise test Willing to wear a Holter monitor for 3 days and respond to surveys on a study provided smartphone KEY EXCLUSION CRITERIA: OLDER HEALTHY COMPARISON History of ischemic heart disease (CAD),prior myocardial infarction History of cardiac disease KEY INCLUSION CRITERIA: YOUNGER HEALTHY (ENROLLMENT CLOSED) Proficient in English 21 to 50 years of age Normal screening ECG without evidence for rhythm abnormalities, conduction abnormalities, hypertrophy, or other pathologies Willing to wear a Holter monitor for 3 days and respond to surveys on a study provided smartphone KEY EXCLUSION CRITERIA: YOUNGER HEALTHY History of ischemic heart disease (CAD), prior myocardial infarction History of cardiac diseases Abnormal ECG

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| YOUNGER HEALTHY NO CORONARY ARTERY DISEASE (CAD)<br>- Whether an association between typical daily experiences and recovery time varies with age; this group will be compared to the older comparison group and to previous data collected from those subjects who participated in the Long QT Syndrome study (LQTS). | |
| OLDER HEALTHY SUBJECTS NO CORONARY ARTERY DISEASE (CAD)<br>- Determine whether daily emotion influences ischemia and repolarization differentially as a function of the severity of CAD and presence of CAD when comparing CAD patients with healthy patients | |
| HIGH RISK CORONARY ARTERY DISEASE (CAD)<br>- Determine whether emotion assessed randomly throughout the day is associated with myocardial ischemia | |
| LOW RISK CORONARY ARTERY DISEASE (CAD)<br>- Determine whether typical daily emotion influences ischemia and repolarization differentially as a function of the severity of CAD and presence of CAD | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To obtain behavioral and cardiovascular data including 4-days collection of data as study participant engages in their daily activities. | 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. | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart disease, unstable angina, myocardial infarction, behavioral, cardiovascular, emotions