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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
  Purpose

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


Condition
Coronary Artery Disease
Behavioral

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Typical Daily Emotions, Ischemia and Repolarization in Coronary Artery Disease

Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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).
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531231

Contacts
Contact: Marcia R Webster, BA, CCRC 520-626-5292 marciar@email.arizona.edu
Contact: Sarah Sharp, BS ssharp@surgery.arizona.edu

Locations
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
Richard Lane
University of Rochester
Investigators
Principal Investigator: Richard D Lane, MD, PhD University of Arizona
  More Information

No publications provided

Responsible Party: Richard Lane, MD, PhD, University of Arizona
ClinicalTrials.gov Identifier: NCT01531231     History of Changes
Other Study ID Numbers: RO1 HL103692-01 A1
Study First Received: February 8, 2012
Last Updated: July 23, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Arizona:
heart disease
unstable angina
myocardial infarction
behavioral
cardiovascular
emotions

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014