Impact of Coronary Images Used During Patient Education on Coronary Artery Disease and Subsequent Lifestyle Modifications. Is a Picture Really Worth a Thousand Words?

Coronary Artery Disease Clinical Trial

Official title:

Impact of Coronary Images Used During Patient Education on Coronary Artery Disease and Subsequent Lifestyle Modifications. Is a Picture Really Worth a Thousand Words?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01275716
• Other study ID #: 10-623-A
• Status: Recruiting
• Phase: N/A
• First received: January 10, 2011
• Last updated: August 23, 2016
• Start date: December 2010
• Est. completion date: December 2020

Study information

• Verified date: August 2016
• Source: University of Chicago
• Contact: Janet Karol
• Phone: (773) 834-8399
• Email: jkarol[@]uchicago.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Subjects in this research study have Coronary Artery Disease (CAD). This occurs when there is a build-up of fatty material in the wall of the heart arteries that causes narrowing of the arteries. This could lead to chest pain, a heart attack, weakening of the heart and/or permanent damage to the heart. As part of their normal routine care, subjects had or will have a Percutaneous Coronary Intervention (PCI) to restore the blood flow in the arteries of their heart. During a PCI procedure, pictures are taken of the arteries before and after the treatment of the narrowing in the arteries. These pictures are acquired through angiography which is a way to produce X-ray pictures of the inside of arteries.

After a PCI procedure, there is a possibility for narrowing of the arteries to return. The likelihood of this happening can be greatly reduced by lifestyle changes and adhering to heart medication regimens. It is part of normal, routine care for CAD patients to be given written and verbal information on how to lead a heart healthy lifestyle and to take heart medications properly.

In this research study, the investigators will show half of the patients their before and after images of their heart arteries where the narrowing occurred and was treated. The other half of the patients will not be shown these images. Both groups will still receive information about lifestyle and medications as part of their normal, routine care. At the end of this study, the investigators will compare both groups to see if there are any differences in making lifestyle changes and taking heart medications properly. Additionally, the investigators would also like to see if there are any resulting differences in the amount of hearts attacks or other heart related medical events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Over the age of 18

2. Able to provide informed consent in English.

3. Undergoing percutaneous coronary intervention for any clinical indication.

Exclusion Criteria:

1. Patients not able to provide informed consent.

2. Patients without a means for telephone communication.

3. Incarcerated individuals and other special populations.

4. Patients unable to or unwilling to reliably participate in telephone followup.

5. Significant neurologic co morbidities such as cerebrovascular accidents with deficit or developmental delays which may impact learning and/or memory

6. Any medical comorbidity which might result in life-expectancy < 1 year

7. Any other condition of sufficient severity to impair cooperation in the study- i.e. substance abuse, etc.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Behavioral:
• Impact of Coronary Images Used During Patient Education on Coronary Artery Disease and Subsequent Lifestyle Modifications
Subjects will be randomly assigned (like the flip of a coin) to a study group. One group will be given before and after treatment pictures of their affected heart arteries. The other group will not be shown these pictures. Both groups will still receive written and verbal information about living a heart healthy lifestyle and taking heart medications properly as part of their normal routine care.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant improvement of patient's knowledge in the group that receives the images versus the group that receives standard education of coronary artery risk factors as measured on questionnaires from baseline to 30 days and at 3 and 6 month follow up		6 months	No
Secondary	The secondary endpoints of the study is a significant improvement in the patient's adherence to nutritional, exercise and medical regimen in the group receiving the images and education versus the group that receives standard education alone		6 months	No
Secondary	An exploratory analysis will assess the impact of the aforementioned educational intervention on the occurrence of major adverse cardiovascular events		6 months	No