Typical Daily Experiences, Ischemia and Repolarization in Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:

Typical Daily Emotions, Ischemia and Repolarization in Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01531231
• Other study ID #: RO1 HL103692-01 A1
• Status: Recruiting
• Phase: N/A
• First received: February 8, 2012
• Last updated: July 23, 2013
• Start date: January 2012
• Est. completion date: February 2015

Study information

• Verified date: July 2013
• Source: University of Arizona
• Contact: Marcia R Webster, BA, CCRC
• Phone: 520-626-5292
• Email: marciar[@]email.arizona.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Behavioral
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Richard Lane	University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No