Systolic Pressure Intervention Trial (SPRINT)-Factors Affecting Factors Affecting Atherosclerosis Study (FAST)

Location:

Jacksonville, Fla.

Trial status:

Open for Enrollment

Why is this study being done?

Systolic Pressure Intervention Trial (SPRINT) is a large scale randomized trial of ~ 9250 adults aged 50 years or older with high cardiovascular risk sponsored by NIH. The study is designed to recruit 45% of the study population with Chronic Kidney Disease (CKD). The trial will test the effects of low systolic blood pressure (SBP) goal of < 120 mm Hg versus the standard goal of < 140 mm Hg on the primary composite of cardiovascular events and death. One of the pre-specified secondary outcome is the progression of kidney disease. In this ancillary named SPRINT - Factors affecting Atherosclerosis STudy (FAST), the investigators plan to take advantage of the unique opportunities afforded by the parent study to examine issues that are of significant public health importance. This is an observational study in SPRINT participants. This study will examine mechanistically, the factors affecting the progression of atherosclerosis in CKD.

Who is eligible to participate?

All potential SPRINT participants at the SPRINT-FAST sites will be screened for eligibility to participate in SPRINT-FAST. The only medical exclusion criterion for SPRINT-FAST is contraindications to MRI (such as intracranial metal prostheses and claustrophobia). If there is no contraindication, the potential SPRINT participant will be asked whether they would also participate in SPRINT-FAST. Additional study procedures (MRI, blood and urine samples) of SPRINT-FAST will be explained. If the potential SPRINT participant consents for SPRINT-FAST, upon meeting the inclusion and exclusion criteria for the parent study, they will be scheduled for MRI. Patients who cannot undergo MRI (weight > 300 lbs, certain types of hardware used in pacemakers, prostheses etc).

Last updated:

12/9/2013

NCT ID:

NCT01475747

IRB Number:

12-006936