Systolic Pressure Intervention Trial Factors Affecting Factors Affecting Atherosclerosis Study (SPRINTFAST)
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| First Received Date ICMJE | November 16, 2011 | ||||||||
| Last Updated Date | January 30, 2013 | ||||||||
| Start Date ICMJE | September 2011 | ||||||||
| Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
CKD and Atherosclerosis [ Time Frame: Baseline and 30 months ] [ Designated as safety issue: No ] To examine
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01475747 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Systolic Pressure Intervention Trial Factors Affecting Factors Affecting Atherosclerosis Study | ||||||||
| Official Title ICMJE | Systolic Pressure Intervention Trial (SPRINT)-Factors Affecting Factors Affecting Atherosclerosis Study (FAST) | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: Urine, plasma and serum samples. |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 600 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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). |
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| Gender | Both | ||||||||
| Ages | 50 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01475747 | ||||||||
| Other Study ID Numbers ICMJE | IRB_00049314, R01DK091437-01 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Srinvasan Beddhu, University of Utah | ||||||||
| Study Sponsor ICMJE | University of Utah | ||||||||
| Collaborators ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Utah | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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