NCT02840851

Brief Summary

Baseline cerebral blood flow through the middle cerebral artery (MCA) and cerebral vasodilator response of the MCA to inhaled carbon dioxide (CO2) will be measured in young women, young men, older women, and older men using Magnetic Resonance (MR) imaging and transcranial Doppler ultrasound (TCD). Data collection techniques will be compared.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

December 9, 2019

Status Verified

December 1, 2019

Enrollment Period

1.8 years

First QC Date

July 19, 2016

Last Update Submit

December 6, 2019

Conditions

Keywords

Magnetic Resonance ImagingTranscranial Doppler UltrasoundHypercapnia

Outcome Measures

Primary Outcomes (2)

  • Middle Cerebral Artery Blood Flow Measurement

    Utilize the TCD and MR imaging to measure middle cerebral artery blood flow in the brain while the participant is at rest.

    75 minutes

  • Middle Cerebral Artery Blood Flow Reactivity to Hypercapnia

    Utilize the TCD and MR imaging to measure middle cerebral artery blood flow reactivity to hypercapnic gas.

    75 minutes

Study Arms (4)

Healthy young women

Healthy young women between the age of 20-34 years.

Device: MRIDevice: TCD

Healthy young men

Healthy young men between the age of 20-34 years.

Device: MRIDevice: TCD

Healthy older women

Healthy older women between the age of 50-64 years.

Device: MRIDevice: TCD

Healthy older men

Healthy older men between the age of 50-64 years.

Device: MRIDevice: TCD

Interventions

MRIDEVICE

Participants will undergo a MRI scan while two stepwise CO2 elevations are applied to the participant by adding fractional concentration of inspired CO2 (FICO2) at 4% and 6% each time. The end tidal CO2 (PetCO2) will be elevated and maintained constant for a few minutes at each target level. Breath-by-breath changes in respiratory rate and PetCO2 will be measured.

Also known as: Magnetic Resonance Imaging
Healthy older menHealthy older womenHealthy young menHealthy young women
TCDDEVICE

Participants will undergo a TCD scan while two stepwise CO2 elevations are applied to the participant by adding fractional concentration of inspired CO2 (FICO2) at 4% and 6% each time. The end tidal CO2 (PetCO2) will be elevated and maintained constant for a few minutes at each target level. Breath-by-breath changes in respiratory and PetCO2 will be measured.

Also known as: Transcranial Doppler Ultrasound
Healthy older menHealthy older womenHealthy young menHealthy young women

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects for this study will include healthy young adults (20-34 years old) and healthy older adults (50-69 years old). Both men and women will be eligible to participate in this study.

You may qualify if:

  • Between 20-34 or 50-69 years
  • Body mass index \<34 kg/m2

You may not qualify if:

  • Current smoker
  • History or evidence of: hepatic disease, renal disease, hematological disease, peripheral vascular disease, stroke/neurovascular disease, diabetes, hypertension
  • Part of a vulnerable population (e.g. pregnant women, prisoner, individuals lacking capacity to consent, etc.)
  • Older females only: subject is not post-menopausal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53706, United States

Location

Related Publications (20)

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    PMID: 16357086BACKGROUND
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    PMID: 15272220BACKGROUND
  • Selim M, Jones R, Novak P, Zhao P, Novak V. The effects of body mass index on cerebral blood flow velocity. Clin Auton Res. 2008 Dec;18(6):331-8. doi: 10.1007/s10286-008-0490-z. Epub 2008 Aug 22.

    PMID: 18726054BACKGROUND
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    PMID: 687900BACKGROUND
  • Barnes JN, Schmidt JE, Nicholson WT, Joyner MJ. Cyclooxygenase inhibition abolishes age-related differences in cerebral vasodilator responses to hypercapnia. J Appl Physiol (1985). 2012 Jun;112(11):1884-90. doi: 10.1152/japplphysiol.01270.2011. Epub 2012 Mar 22.

    PMID: 22442028BACKGROUND
  • Lipsitz LA, Mukai S, Hamner J, Gagnon M, Babikian V. Dynamic regulation of middle cerebral artery blood flow velocity in aging and hypertension. Stroke. 2000 Aug;31(8):1897-903. doi: 10.1161/01.str.31.8.1897.

    PMID: 10926954BACKGROUND
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    PMID: 19246701BACKGROUND
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    PMID: 19443808BACKGROUND
  • Celermajer DS, Sorensen KE, Bull C, Robinson J, Deanfield JE. Endothelium-dependent dilation in the systemic arteries of asymptomatic subjects relates to coronary risk factors and their interaction. J Am Coll Cardiol. 1994 Nov 15;24(6):1468-74. doi: 10.1016/0735-1097(94)90141-4.

    PMID: 7930277BACKGROUND
  • Panza JA, Quyyumi AA, Brush JE Jr, Epstein SE. Abnormal endothelium-dependent vascular relaxation in patients with essential hypertension. N Engl J Med. 1990 Jul 5;323(1):22-7. doi: 10.1056/NEJM199007053230105.

    PMID: 2355955BACKGROUND
  • Kugiyama K, Kerns SA, Morrisett JD, Roberts R, Henry PD. Impairment of endothelium-dependent arterial relaxation by lysolecithin in modified low-density lipoproteins. Nature. 1990 Mar 8;344(6262):160-2. doi: 10.1038/344160a0.

    PMID: 2106627BACKGROUND
  • Luscher TF, Diederich D, Siebenmann R, Lehmann K, Stulz P, von Segesser L, Yang ZH, Turina M, Gradel E, Weber E, et al. Difference between endothelium-dependent relaxation in arterial and in venous coronary bypass grafts. N Engl J Med. 1988 Aug 25;319(8):462-7. doi: 10.1056/NEJM198808253190802.

    PMID: 3136329BACKGROUND
  • Mitchell GF, van Buchem MA, Sigurdsson S, Gotal JD, Jonsdottir MK, Kjartansson O, Garcia M, Aspelund T, Harris TB, Gudnason V, Launer LJ. Arterial stiffness, pressure and flow pulsatility and brain structure and function: the Age, Gene/Environment Susceptibility--Reykjavik study. Brain. 2011 Nov;134(Pt 11):3398-407. doi: 10.1093/brain/awr253.

    PMID: 22075523BACKGROUND
  • Ide K, Eliasziw M, Poulin MJ. Relationship between middle cerebral artery blood velocity and end-tidal PCO2 in the hypocapnic-hypercapnic range in humans. J Appl Physiol (1985). 2003 Jul;95(1):129-37. doi: 10.1152/japplphysiol.01186.2002.

    PMID: 19278048BACKGROUND
  • Ivancev V, Bakovic D, Obad A, Breskovic T, Palada I, Joyner MJ, Dujic Z. Effects of indomethacin on cerebrovascular response to hypercapnea and hypocapnea in breath-hold diving and obstructive sleep apnea. Respir Physiol Neurobiol. 2009 May 15;166(3):152-8. doi: 10.1016/j.resp.2009.03.001. Epub 2009 Mar 18.

    PMID: 19442931BACKGROUND
  • Xie A, Skatrud JB, Morgan B, Chenuel B, Khayat R, Reichmuth K, Lin J, Dempsey JA. Influence of cerebrovascular function on the hypercapnic ventilatory response in healthy humans. J Physiol. 2006 Nov 15;577(Pt 1):319-29. doi: 10.1113/jphysiol.2006.110627. Epub 2006 Aug 24.

    PMID: 16931556BACKGROUND
  • Mendelsohn ME, Karas RH. The protective effects of estrogen on the cardiovascular system. N Engl J Med. 1999 Jun 10;340(23):1801-11. doi: 10.1056/NEJM199906103402306. No abstract available.

    PMID: 10362825BACKGROUND
  • Newell DW, Aaslid R, Lam A, Mayberg TS, Winn HR. Comparison of flow and velocity during dynamic autoregulation testing in humans. Stroke. 1994 Apr;25(4):793-7. doi: 10.1161/01.str.25.4.793.

    PMID: 7909175BACKGROUND
  • Coverdale NS, Badrov MB, Shoemaker JK. Impact of age on cerebrovascular dilation versus reactivity to hypercapnia. J Cereb Blood Flow Metab. 2017 Jan;37(1):344-355. doi: 10.1177/0271678X15626156. Epub 2016 Jan 12.

    PMID: 26759432BACKGROUND
  • Miller KB, Howery AJ, Rivera-Rivera LA, Johnson SC, Rowley HA, Wieben O, Barnes JN. Age-Related Reductions in Cerebrovascular Reactivity Using 4D Flow MRI. Front Aging Neurosci. 2019 Oct 17;11:281. doi: 10.3389/fnagi.2019.00281. eCollection 2019.

MeSH Terms

Conditions

Hypercapnia

Interventions

Magnetic Resonance ImagingUltrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisEchoencephalographyNeuroradiographyNeuroimagingRadiographyUltrasonographyUltrasonography, DopplerDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Jill N Barnes, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2016

First Posted

July 21, 2016

Study Start

November 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

December 9, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations