Typical Daily Experiences, Ischemia and Repolarization in Coronary Artery Disease
This study is currently recruiting participants.
Verified June 2012 by University of Arizona
Sponsor:
Richard Lane
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: June 19, 2012
Last verified: June 2012
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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 |
Resource links provided by NLM:
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 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.
| 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 CAD
- Whether an association between typical daily experiences and recovery time varies with age
|
|
OLDER HEALTHY SUBJECTS NO 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; Word-of-Mouth; Craig's List
Criteria
INCLUSION CRITERIA: LOW RISK CAD SUBJECTS, EJECTION FRACTION >35%
- Proficient in English
- At least 21 years of age or older
- Stable coronary artery disease
- Currently,or within last 3 years diagnosed with at least 2-vessel disease with a minimum of 30% narrowing in at least one of the vessels
- Exhibit sinus rhythm on a recent EKG (<3 months ago)
- Willing to participant in 3 days of Holter monitor recordings and ecological momentary assessments (EMA)
EXCLUSION CRITERIA: LOW RISK CAD SUBJECTS, EJECTION FRACTION > 35%
- Suicidal ideation
- Cognitive impairment
- Exhibits symptoms of active psychosis
- Recent bereavement or acute stress one month prior to participation
- Prescribed benzodiazepine (prn: ok); tricyclic antidepressant, or medication with strong anticholinergic properties used daily.
- History of stroke, intracranial lesion, organic brain damage, or traumatic brain injury
- Diagnosed with or exhibit signs of dementia
- Known neurological condition (e.g. Parkinson's disease)
- Diagnosed with chronic pain
- Plan to have elective revascularization
- History of atrial fibrillation or evidence of atrial fibrillation or atrial flutter on the screening ECG or any prior ECGs.
- Implanted pacemaker
- Presence of bundle branch block evident on ECG
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 with the last myocardial ischemia or unstable angina episode >3months ago, and 3 months after last active coronary syndrome
- Diagnosed with at least 2-vessel disease with a minimum of 30% narrowing in at least one of the vessels at the present time (based on Cath report within last 5 years)
- Exhibit sinus rhythm on recent ECG (<3 months ago)
- Recent ECHO, MUGA or angiography (< 2year old) reflect a left-ventricular ejection fraction <35%
- Single-chamber cardioverter-defibrillator, implanted for ischemic cardiomyopathy, with a back up rate of ventricular pacing at < 45 bpm
- Willing to wear a Holter monitor for 3 days and complete ecological momentary assessments
EXCLUSION CRITERIA: HIGH RISK CAD, Ejection Fraction <35%
- Exhibit active suicidal ideation
- Exhibit signs of active psychosis
- Recent bereavement or acute stress during the month prior to participation
- Prescribed benzodiazepine (prn: ok); tricyclic antidepressant, or medication with strong anticholinergic properties used daily.
- History of stroke, intracranial lesion, organic brain damage, or traumatic brain injury
- Diagnosed with or exhibit signs of dementia
- Known neurological condition (e.g. Parkinson's disease)that may interfere with collection of trial data
- Diagnosed with chronic pain
- Plan to have elective revascularization
- History of atrial fibrillation or evidence of atrial fibrillation or atrial flutter on the screening ECG or any prior ECGs
- An implanted dual chamber ICD or a cardiac resynchronization pacemaker with ICD
- Heart rhythm artificially continuously paced
- Presence of a bundle branch block evident on any ECG
- Willing to wear a Holter monitor for 3 days and complete ecological momentary assessments
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 exercise or echo testing
- Willing to wear a Holter monitor for 3 days and complete ecological momentary assessments
EXCLUSION CRITERIA: OLDER HEALTHY COMPARISON
- History of ischemic heart disease (CAD),prior myocardial infarction
- History of cardiac disease
- History of atrial fibrillation or evidence for atrial fibrillation or atrial flutter in implanted pacemaker or ICD
INCLUSION CRITERIA: YOUNGER HEALTHY
- 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 complete ecological momentary assessments
EXCLUSION CRITERIA: YOUNGER HEALTHY
- History of ischemic heart disease (CAD), prior myocardial infarction
- History of cardiac diseases
- History of atrial fibrillation or evidence for atrial fibrillation or atrial flutter in screening ECG or prior available ECGs
Contacts and Locations
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: Carolyn Fort, BS | 520-626-8568 | cfort@email.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: | June 19, 2012 |
| 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 Myocardial Ischemia Coronary Disease Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013