Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00770679
• Collaborator: Pfizer (Industry)
• Enrollment: 16
• Location: 1
• Arm: 1
• Actual Duration (Months): 49
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Cholesterol-lowering drugs called statins improve the functioning of the endothelium, and help prevent heart disease. The investigators are testing whether statins improve endothelial function more in the arteries that have worse endothelium to begin with. One of the functions of the endothelium is to help control how blood vessels dilate (expand) or contract (narrow) in different situations. This affects how blood flows through those vessels. Magnetic resonance imaging (MRI) can be used to evaluate endothelial function in the arms and legs noninvasively.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Drug: lipitor	N/A

Detailed Description

Correct

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging
• Actual Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High-Dose Statin 80 mg atorvastatin daily for 3 weeks	Drug: lipitor; 80 mg everyday (QD) for 3 weeks; Other Names: atorvastatin

Outcome Measures

Primary Outcome Measures

1. Mean Change in Low Density Lipoprotein (LDL) [Change from baseline to follow-up, up to 5 weeks]

   Serum LDL, mg/dL (baseline LDL-follow-up LDL)

2. Change in Endothelial Function as Measured on MRI in the Arms [chance from baseline to end of study, up to 5 weeks]

3. Change in Endothelial Function as Measured on MRI in the Legs [chance from baseline to end of study, up to 5 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 40-90

• Male or female

• Type 2 diabetes

Exclusion Criteria:

• Known pregnancy or nursing.

• Females of child bearing potential must have been surgically sterilized or be post menopausal.

• Smoking

• Known vascular disease

• Inability to complete MRI scan

• Symptoms of claudication

• Use of a nitrate medicine

• Use of any cholesterol-lowering agent

• LDL < 70

• Acute illness

• Liver disease

• Contraindication to getting an MRI scan (i.e. electronic implant, shrapnel, cerebral aneurysm clip, welding history).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harry SIlber, MD	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

• Johns Hopkins University
• Pfizer

Investigators

• Principal Investigator: Harry Silber, MD, JHU

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00770679
• Other Study ID Numbers: NA00002253
• First Posted: Oct 10, 2008
• Last Update Posted: Sep 13, 2017
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Atorvastatin

Study Results

Participant Flow

Arm/Group Title	High-Dose Statin
Arm/Group Description	80 mg atorvastatin daily for 3 weeks lipitor: 80 mg everyday (QD) for 3 weeks
Period Title: Overall Study
STARTED	16
COMPLETED	10
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	High-Dose Statin
Arm/Group Description	80 mg atorvastatin daily for 3 weeks lipitor: 80 mg everyday (QD) for 3 weeks
Overall Participants	16
Age, Customized (Count of Participants)
>=40, <=90, years	16 100%
Sex: Female, Male (Count of Participants)
Female	6 37.5%
Male	10 62.5%
Region of Enrollment (Count of Participants)
United States	16 100%

Outcome Measures

1. Primary Outcome

Title	Mean Change in Low Density Lipoprotein (LDL)
Description	Serum LDL, mg/dL (baseline LDL-follow-up LDL)
Time Frame	Change from baseline to follow-up, up to 5 weeks

Outcome Measure Data

Analysis Population Description

3 participants were lost to follow-up, 3 participants did not have LDL values collected/reported at follow-up

Arm/Group Title	High-Dose Statin
Arm/Group Description	80 mg atorvastatin daily for 3 weeks lipitor: 80 mg everyday (QD) for 3 weeks
Measure Participants	10
Mean (Standard Deviation) [mg/dL]	75.54 (12.98)

2. Primary Outcome

Title	Change in Endothelial Function as Measured on MRI in the Arms
Time Frame	chance from baseline to end of study, up to 5 weeks

Outcome Measure Data

Analysis Population Description

No data was collected for this outcome measure. The outcome was not able to be calculated based upon data obtained and programs and investigator capabilities.

Arm/Group Title	High-Dose Statin
Arm/Group Description	80 mg atorvastatin daily for 3 weeks lipitor: 80 mg everyday (QD) for 3 weeks
Measure Participants	0

3. Primary Outcome

Title	Change in Endothelial Function as Measured on MRI in the Legs
Time Frame	chance from baseline to end of study, up to 5 weeks

Outcome Measure Data

Analysis Population Description

No data was collected for this outcome measure. The outcome was not able to be calculated based upon data obtained and programs and investigator capabilities.

Arm/Group Title	High-Dose Statin
Arm/Group Description	80 mg atorvastatin daily for 3 weeks lipitor: 80 mg everyday (QD) for 3 weeks
Measure Participants	0

Adverse Events

Arm/Group Title	High-Dose Statin
Arm/Group Description	80 mg atorvastatin daily for 3 weeks lipitor: 80 mg everyday (QD) for 3 weeks
All Cause Mortality
	High-Dose Statin
	Affected / at Risk (%)	# Events
Total	0/16 (0%)
Serious Adverse Events
	High-Dose Statin
	Affected / at Risk (%)	# Events
Total	0/16 (0%)
Other (Not Including Serious) Adverse Events
	High-Dose Statin
	Affected / at Risk (%)	# Events
Total	0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.