Typical Daily Experiences, Ischemia and Repolarization in Coronary Artery Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Arizona
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Richard Lane, University of Arizona
ClinicalTrials.gov Identifier:
NCT01531231
First received: February 8, 2012
Last updated: July 23, 2013
Last verified: July 2013

February 8, 2012
July 23, 2013
January 2012
January 2015   (final data collection date for primary outcome measure)
To obtain behavioral and cardiovascular data including 4-days collection of data as study participant engages in their daily activities. [ Time Frame: 4 days ] [ Designated as safety issue: No ]
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.
To obtain behavioral and cardiovascular data including 4-days collection of data as study participant engages in their daily activities. [ Time Frame: 4 days ] [ Designated as safety issue: No ]
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 repolarzation 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.
Complete list of historical versions of study NCT01531231 on ClinicalTrials.gov Archive Site
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Typical Daily Experiences, Ischemia and Repolarization in Coronary Artery Disease
Typical Daily Emotions, Ischemia and Repolarization in Coronary Artery Disease

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

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).
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

University of Arizona Medical Center (overhead TV monitors); Cardiology Clinics; Community Centers; Primary Care Clinics; Pima Heart; Desert Cardiology; Referrals from study participants, Craig's List

  • Coronary Artery Disease
  • Behavioral
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
February 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
21 Years and older
Yes
Contact: Marcia R Webster, BA, CCRC 520-626-5292 marciar@email.arizona.edu
Contact: Sarah Sharp, BS ssharp@surgery.arizona.edu
United States
 
NCT01531231
RO1 HL103692-01 A1
No
Richard Lane, University of Arizona
Richard Lane
University of Rochester
Principal Investigator: Richard D Lane, MD, PhD University of Arizona
University of Arizona
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP