Correlation Between Coronary and Carotid Atherosclerotic Disease and Links With Clinical Outcomes

Status:	Completed
Conditions:	Peripheral Vascular Disease, Cardiology, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 87
Updated:	8/30/2017
Start Date:	May 2012
End Date:	December 12, 2016

Global Observational Study to Evaluate the Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes

The relationship of the natural history of atherosclerosis between different vascular beds
has not been well characterized. Determination and comparison of the relative rates of
progression and extents of atherosclerosis in the coronary and carotid arterial trees may
have major impacts on clinical research and clinical practice. Correlation between findings
in the carotid and coronary circulations is an important scientific and clinical topic to
address. Results from a well design study incorporating imaging technologies that currently
represent the gold standards for the assessment of coronary and carotid artery plaque burden,
will have potentially impact on clinical research and clinical practice.

This is a prospective, observational, multi-center study expecting to enroll approximately
500 patients who have successfully undergone baseline imaging in the dal-PLAQUE 2 study.

- Patients who have had baseline angiography and IVUS, with or without baseline carotid
ultrasound IMT assessments but NOT undergone follow-up angiography and IVUS as part of
the dal-PLAQUE 2 study to have a follow-up angiogram and IVUS performed within 18-27
months of their baseline imaging.

- Patients who have had baseline carotid ultrasound IMT assessments but NOT undergone a
follow-up carotid ultrasound IMT assessment within 18-27 months following enrollment
into dal-PLAQUE 2 to have a follow up carotid ultrasound examination performed within
18-27 months of their baseline imaging.

- Patients to be contacted by phone on a annual bases at 3, 4, and 5 years following
randomization into dal-PLAQUE 2 to collect cardiovascular and cerebrovascular clinical
endpoints.

Inclusion Criteria:

- written informed consent

- patients who have successfully undergone baseline IVUS imaging, with or without
baseline carotid ultrasound IMT assessment, in the dal-PLAQUE 2 study

Exclusion Criteria:

- none applicable

We found this trial at

sites

Sarasota Memorial Hospital

1700 S Tamiami Trail
Sarasota, Florida 34239

(941) 917-9000