Typical Daily Experiences, Ischemia and Repolarization in Coronary Artery Disease

Richard Lane

Status: Completed

Conditions: Behavioral; Coronary Artery Disease

Study type: Observational

Funder types: Other

Identifiers

NCT01531231

R01HL103692-01A1

Details and patient eligibility

About

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

Full 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).

Enrollment: 301 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 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

Trial design

301 participants in 4 patient groups

YOUNG HEALTHY NO CORONARY ARTERY DISEASE

Description:

- 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 NO CORONARY ARTERY DISEASE

Description:

- 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)

Description:

- Determine whether emotion assessed randomly throughout the day is associated with myocardial ischemia

LOW RISK CORONARY ARTERY DISEASE (CAD)

Description:

- Determine whether typical daily emotion influences ischemia and repolarization differentially as a function of the severity of CAD and presence of CAD