Typical Daily Experiences, Ischemia and Repolarization in Coronary Artery Disease

NCT01531231 | Completed

• 1 other identifier: R01HL103692-01A1
• Study Type: observational
• Target: 301
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease; Behavioral

Keywords

heart disease; unstable angina; myocardial infarction; behavioral; cardiovascular; emotions

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

YOUNG HEALTHY NO CORONARY ARTERY DISEASE

\- 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

\- 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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• \- Presence of bundle branch block evident on ECG
• Proficient in English
• 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
• An implanted cardiac resynchronization pacemaker with ICD (CRT-D)
• Heart rhythm artificially continuously paced
• Presence of a bundle branch block evident on any ECG
• Proficient in English
• 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

Sponsors & Collaborators

• Richard Lane: lead
• University of Rochester: collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Behavior; Heart Diseases; Angina, Unstable; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Richard D Lane, MD, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: February 10, 2012
• Study Start: June 2, 2011
• Primary Completion: March 24, 2016
• Study Completion: March 29, 2016
• Last Updated: December 2, 2024

Record last verified: 2024-11

Locations

US (1)