Enhanced External Counterpulsation and Its Effects on Vascular Hemodynamics in Cognitively Impaired Patients

Mild Cognitive Impairment Clinical Trial

Official title:

Enhanced External Counterpulsation and Its Effects on Vascular Hemodynamics in Cognitively Impaired Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01659398
• Other study ID #: 13106
• Status: Completed
• Phase: Phase 0
• First received: August 3, 2012
• Last updated: January 12, 2016
• Start date: June 2012
• Est. completion date: October 2014

Study information

• Verified date: January 2016
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate whether enhanced external counterpulsation (EECP) therapy for 7 consecutive weeks will improve cerebral blood flow and possibly over time enhance or slow down breakdown of cognitive function in patients diagnosed with mild cognitive impairment (MCI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• An adult between 18 and 85 years of age.

• Has been evaluated to have a CDR (Clinical Dementia Rating) Score of 0.5

• Male or female (if female must be postmenopausal for at least 1 year, surgically sterile or using an effective form of contraception).

• Able to speak and read English.

• Willing to comply with study specific instructions, and complete all study procedures according to protocol.

• Able to understand study rationale and sign informed consent.

Exclusion Criteria:

• Diagnosed with glaucoma

• History of developing adverse effects to ophthalmic dilating agents (phenylephrine or tropicamide).

• Currently taking warfarin and dabigatran (Pradaxa).

• History of having arrhythmias - can interfere with EECP triggering.

• Subject has bleeding diathesis.

• Subject has active thrombophlebitis.

• Subject has severe lower extremity vaso-occlusive disease.

• Subject has a documented aortic aneurysm requiring surgical repair.

• Subject is pregnant.

• Subject with blood pressure higher than 180/110 mmHg.

• Subject with a heart rate more than 120 bpm.

• Subject with high risk of complications from increased venous return.

• Subject with clinically significant valvular disease.

• Subjects with severe vascular disease as established by the Hachinski Ischemic Index.

• Subjects with pacemakers and other metallic implantable devices.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Device:
• External Counterpulsation (EECP)
A noninvasive neuroimaging technique. Administration of 35 hours EECP therapy over a 7 week period. EECP to be administered for 1 hour, 5 times a week.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Patrick Moriarty, MD, FACP, FACC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cognitive Function	Change in cognitive function measured using the Alzheimer's Disease Assessment Scale-cognitive sub-scale (ADAS-cog). Scale is used to determine patient's mental status. The scale has 11 parts and scores range from 0 (no impairment) to 70 (severe impairment).	Baseline, Week 7, 6 Month	No
Secondary	Change in Ophthalmic blood flow (OBF)		Baseline to Week 7	No
Secondary	Change in Blood Viscosity		Baseline to Week 7	No
Secondary	Cholesterol composition of the blood		Baseline to week 7	No

External Links

•   University of Kansas Clinical Pharmacology Homepage