Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01275716
Other study ID # 10-623-A
Secondary ID
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
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


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.


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, 


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
See also
  Status Clinical Trial Phase
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Terminated NCT02528474 - Comparison of Optical Coherence Tomographic Findings After Balloon Angioplasty With Two Different Paclitaxel-Coated Balloons for the Treatment of In-Stent Restenosis in Drug-Eluting Stents N/A
Recruiting NCT03471234 - Latin America Real World Study With Inspiron Drug Eluting Stent - INSPIRON LATITUDE
Completed NCT02115308 - Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging Phase 4
Terminated NCT01374555 - Evaluation of the CardioSond Electronic Stethoscope in the Detection of Coronary Artery Disease
Active, not recruiting NCT03216720 - Miniaturized Extracorporeal Circulation Study N/A
Completed NCT03226262 - FFRangio Accuracy vs. Standard FFR
Recruiting NCT03378934 - Anti-platelet Effect of Berberine in Patients After Elective Percutaneous Coronary Intervention Phase 4
Recruiting NCT03707626 - Collateral Circulation to LAD and Wellens Sign
Recruiting NCT03622671 - Fibrin Clot Properties and Blood Loss Following Coronary Artery By-pass Grafting N/A
Completed NCT01930214 - Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)
Recruiting NCT03709836 - Computed Tomography Angiography Prediction Score for Side Branch Occlusion
Completed NCT02272582 - A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing CABG (STEPS) N/A
Recruiting NCT03265535 - Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging
Not yet recruiting NCT03265041 - Long Term Predictors of Graft Patency After Coronary Artery Bypass Graft Surgery (Multi-slice CT Coronary Angiography Study Validated by Coronary Angiography)
Not yet recruiting NCT03646019 - Serum Oxidative Status as a Potential Predictor of Coronary Artery Disease.
Recruiting NCT02939729 - Physiotherapy Prehabilitation in Patients Undergoing Cardiac or Thoracic Surgery N/A
Recruiting NCT02922088 - EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits With DuraGraft [VASC] N/A
Recruiting NCT03027856 - The BIFSORB Pilot Study II N/A
Recruiting NCT02832115 - Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention Phase 4