Coronary Artery DiseaseNCT01531231
Typical Daily Experiences, Ischemia and Repolarization in Coronary Artery Disease
An observational study of Coronary Artery Disease and Behavioral, run by Richard Lane at 1 site in United States.
Trial summary
The purpose of this study is to examine the role of every day experiences as they relate to coronary artery disease (CAD). Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Behavioral
- How many people
- 301 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2011to 29 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
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- Willing to wear a Holter monitor for 3 days and respond to surveys on a study provided smartphone
- 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
Who cannot join
- 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%
Show all 17Show fewer
- 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
- History of ischemic heart disease (CAD),prior myocardial infarction
- History of cardiac disease
- History of ischemic heart disease (CAD), prior myocardial infarction
- History of cardiac diseases
- Abnormal ECG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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).
- Conditions
- Coronary Artery Disease, Behavioral
- Keywords
- heart disease, unstable angina, myocardial infarction, behavioral, cardiovascular, emotions
- Medical subject headings
- Coronary Artery Disease, Behavior, Heart Diseases, Angina, Unstable, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study start2 Jun 2011
- Primary completion24 Mar 2016
- Study completion29 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richard Lane
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rochester
- Responsible party
- Sponsor-investigator, Richard Lane, University of Arizona
- Investigators
- Richard D Lane, MD, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531231
- Sponsor's protocol ID
- R01HL103692-01A1
- Status last verified
- Nov 2024
- First submitted
- 8 Feb 2012
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Typical Daily Emotions, Ischemia and Repolarization in Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01531231
- Acronym / sponsor ID
- R01HL103692-01A1
- Conditions
- Coronary Artery Disease, Behavioral
- Keywords
- heart disease, unstable angina, myocardial infarction, behavioral, cardiovascular, emotions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Richard LaneUniversity, hospital or other
- Collaborators
- University of Rochester
- Study start
- 2 Jun 2011 (actual)
- Primary completion
- 24 Mar 2016 (actual)
- Study completion
- 29 Mar 2016 (actual)
- First posted
- 10 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the role of every day experiences as they relate to coronary artery disease (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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To obtain behavioral and cardiovascular data including 4-days collection of data as study participant engages in their daily activities.
Time frame: 4 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard D Lane, MD, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Behavioral, run by Richard Lane at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.