Systolic Pressure Intervention Trial Factors Affecting Factors Affecting Atherosclerosis Study
SPRINTFAST
2 other identifiers
observational
595
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2011
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 16, 2011
CompletedFirst Posted
Study publicly available on registry
November 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJanuary 4, 2019
January 1, 2019
7.3 years
November 16, 2011
January 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Development Rate of Atherosclerosis
Correlation of the presence of CKD and rate of progression of atherosclerosis as assessed by magnetic resonance imaging (MRI) of the carotid artery.
Baseline and 30 months
Study Arms (1)
Observational - SPRINT trial subjects
Subjects in the Systolic Pressure Intervention Trial (SPRINT) observed to examine factors that affect atherosclerosis in chronic kidney disease
Eligibility Criteria
Clinical characteristics of the SPRINT-FAST population will reflect those of the parent study. In this ancillary study, one non-CKD participant (control) will be recruited for each CKD participant (case). SPRINT CKD stratum will likely comprise of those with eGFR between 20-59 ml/min/1.73 m2.
You may qualify if:
- Systolic Pressure Intervention Trial (SPRINT) participants
You may not qualify if:
- Contraindications to MRI (such as intracranial metal prostheses, weight \> 300 pounds, claustrophobia and certain types of hardware used in pacemakers, prostheses, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Stanford University
Palo Alto, California, 94340, United States
University of Colorado Denver
Denver, Colorado, 80045, United States
George Washington University
Washington D.C., District of Columbia, 20052, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Wake Forest University
Winston-Salem, North Carolina, 27109, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Pennsylvania
Pittsburgh, Pennsylvania, 15213, United States
University of Pittsburg
Pittsburgh, Pennsylvania, 15260, United States
University of Utah
Salt Lake City, Utah, 84103, United States
University of Washington
Seattle, Washington, 98195, United States
Related Publications (1)
Beddhu S, Boucher RE, Sun J, Balu N, Chonchol M, Navaneethan S, Chertow GM, Townsend R, Haley W, Cheung AK, Conroy MB, Raj DS, Xu D, George T, Yunis R, Wei G, Canton G, Bates J, Chen J, Papademetriou V, Punzi H, Wiggers A, Wright JT, Greene T, Yuan C. Chronic kidney disease, atherosclerotic plaque characteristics on carotid magnetic resonance imaging, and cardiovascular outcomes. BMC Nephrol. 2021 Feb 24;22(1):69. doi: 10.1186/s12882-021-02260-x.
PMID: 33627066DERIVED
Biospecimen
Urine, plasma and serum samples.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Srinivasan Beddhu, MD
University of Utah
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Assiociate Professor of Medicine
Study Record Dates
First Submitted
November 16, 2011
First Posted
November 21, 2011
Study Start
September 1, 2011
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
January 4, 2019
Record last verified: 2019-01