Typical Daily Experiences, Ischemia and Repolarization in Coronary Artery Disease

Sponsor

Richard Lane (Other)

Overall Status

Unknown status

CT.gov ID

NCT01531231

Collaborator

University of Rochester (Other)

300

Enrollment

Location

Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Behavioral

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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Typical Daily Emotions, Ischemia and Repolarization in Coronary Artery Disease

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Jan 1, 2015

Anticipated Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
YOUNGER HEALTHY NO CORONARY ARTERY DISEASE (CAD) - 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) - 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) - Determine whether emotion assessed randomly throughout the day is associated with myocardial ischemia
LOW RISK CORONARY ARTERY DISEASE (CAD) - Determine whether typical daily emotion influences ischemia and repolarization differentially as a function of the severity of CAD and presence of CAD

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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