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Cerebrovascular CirculationNCT04391465

Assessment of the Relationship Between Cerebral Blood Flow and Heart Rate

A study testing Electrophysiological Pacing in people with Cerebrovascular Circulation and Physiology, run by University of Calgary at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The investigators will seek to determine the relationship between heart rate and middle cerebral artery (MCA) cerebral blood flow (CBF), as well as better understand the hemodynamic determinants of MCA CBF velocity. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Cerebrovascular Circulation, Physiology
What is being tested?
Electrophysiological Pacing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
11 Aug 2021to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female
  • Age 18-70 years, inclusive
  • Scheduled for clinically indicated elective electrophysiological studies where temporary pacing catheters are being placed in the right atrium
  • Left ventricular ejection fraction ≥50%
  • Able and willing to provide informed consent
  • Able to travel to the Cardiac Electrophysiology Laboratory at the Foothills Medical Centre, Calgary, Alberta, Canada

Who cannot join

  • Unable or unwilling to provide informed consent
  • Other factors which in the investigator's opinion would prevent the participant from completing the protocol

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Satish R Raj, MD MSCI contact

403-210-6152

satish.raj@ucalgary.ca

Canada1 site, 1 recruiting
  • Foothills Medical Center

    Calgary, Alberta, T2N 4Z6

    Satish Raj, MD MSCI, 4032106152, autonomic.research@ucalgary.ca

    Recruiting

Other trials in Canada

About this study

Official title: Assessment of the Relationship Between Cerebral Blood Flow and Heart Rate: An Electrophysiology Based Study

The investigators will seek to determine the relationship between heart rate and middle cerebral artery (MCA) cerebral blood flow (CBF), as well as better understand the hemodynamic determinants of MCA CBF velocity. In order to manipulate heart rate, the investigators will recruit patients already scheduled for clinically indicated elective electrophysiological studies, where temporary pacing catheters placed in the right atrium can be used to artificially pace the heart at controlled rates. MCA CBF will be measured by transcranial Doppler ultrasound.

Read the detailed description

Background: Cerebral blood flow (CBF) is maintained at a relatively constant level by multiple overlapping auto-regulatory systems over a wide range of blood pressures. This ensures adequate oxygen delivery to the brain and is critical to ongoing brain function and consciousness. Patients with reduced CBF experience symptoms of presyncope (e.g. lightheadedness, dizziness, trouble concentrating) and may faint. In patients with postural tachycardia syndrome (POTS), these orthostatic symptoms are a chronic issue, but the underlying pathophysiology is poorly understood - there is both evidence for and against impaired cerebral auto-regulation in POTS patients.

Previous studies have demonstrated that increased cardiac output improves CBF independent of mean blood pressure. This is of particular interest in POTS patients, who display reduced cardiac output both during rest and orthostasis. This is due in part smaller heart size and reduced blood volume, which necessitate high heart rates to maintain cardiac output. The relationship between cardiac output and CBF has not been studied in POTS patients. Given the characteristic orthostatic tachycardia seen in these patients, the effects of heart rate on CBF are also of interest. The relationship between heart rate and CBF, to our knowledge, has not been studied.

The chronic orthostatic symptoms in POTS patients are largely unexplained, but contributed centrally to significantly reduced quality of life. These symptoms are thought to be caused in part by alterations in CBF. While POTS does not have a "cure", alleviation of orthostatic symptoms would likely improve patients' ability to engage with activities of daily living and may reduce overall disease burden. Gaining an improved understanding of the hemodynamic determinants of CBF is essential to achieving this goal.

Objectives: To assess the relationship between heart rate and middle cerebral artery (MCA) CBF. Additionally, to better understand the hemodynamic determinants of MCA CBF velocity by examining the relationships between heart rate, stroke volume, pulse pressure, and MCA CBF velocity.

Methods: This will be an open-label, single group study in otherwise healthy patients scheduled for elective electrophysiology studies prior to planned ablations for supraventricular tachycardia. The study will take place with the participant supine on the electrophysiology laboratory procedure table, with a temporary pacing catheter already placed in the high right atrium. Prior to beginning the study protocol, the participant will be instrumented with non-invasive (a) skin electrodes to continuously monitor heart rate and record an electrocardiogram; (b) a volume-clamp finger cuff to monitor beat-to-beat blood pressure, calibrated with intermittent brachial cuff measurements; and (c) a transcranial Doppler System to record CBF velocity. Estimates of stroke volume, cardiac output, and systemic vascular resistance will be obtained using Modelflow-based waveform analysis of the continuous blood pressure waveform. A clinically standard sinus node recovery time (SNRT) protocol will be performed whilst collecting CBF and hemodynamic responses. Pacing will occur at 600 ms (100 bpm), 500 ms (120 bpm), 400 ms (150 bpm), and 350 ms (171 bpm) cycles for 60 seconds each, with a rest period of at least 60 seconds between pacing runs. After these pacing runs, the study data collection will be complete and the extra blood pressure cuffs and transcranial doppler probes will be removed from the participant so that the clinical electrophysiology study may continue as planned. The investigators estimate that this study will add no more than 10-15 minutes to the overall procedure time.

In this exploratory "proof of concept" study, the investigators plan to enrol 20 participants.

Being tested
Electrophysiological Pacing
Keywords
Cerebral Blood Flow

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electrophysiological PacingOther

    Assess the MCA CBF velocity response at different paced heart rates.

Study groups in NCT04391465
Study groupRoleWhat they receive
Patients Scheduled for Elective Electrophysiological StudyExperimentalHigh right atrial pacing will occur at the following rates for 60 seconds each, with a rest period of at least 60 seconds between pacing runs: * 600 msec (100 bpm) * 500 msec (120 bpm) * 400 msec (150 bpm) * 350 msec (171 bpm)
Receives: Other: Electrophysiological Pacing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in MCA CBF velocity in response to high right atrial pacing at 400 ms (150 bpm) relative to baseline while in the supine position

    Compare the MCA CBF velocity at the participant's own baseline sinus rhythm (<100 bpm) and during pacing at 400 ms (150 bpm)

    Measured: After 1 minute of pacing at 400 ms (150 bpm)

Secondary outcomes (7)
  1. Change in MCA CBF velocity in response to high right atrial pacing at 600 ms (100 bpm) relative to baseline while in the supine position

    Compare the MCA CBF velocity at the participant's own baseline sinus rhythm (<100 bpm) and during pacing at 600 ms (100 bpm)

    Measured: After 1 minute of pacing at 600 ms (100 bpm)

  2. Change in MCA CBF velocity in response to high right atrial pacing at 350 ms (171 bpm) relative to baseline while in the supine position

    Compare the MCA CBF velocity at the participant's own baseline sinus rhythm (<100 bpm) and during pacing at 350 ms (171 bpm)

    Measured: After 1 minute of pacing at 350 ms (171 bpm)

  3. Change in MCA CBF velocity in response to high right atrial pacing at 400 ms (150 bpm) relative to pacing at the lowest rate (100 bpm) while in the supine position

    Compare the MCA CBF velocity during pacing at 600 ms (100 bpm) and during pacing at 400 ms (150 bpm)

    Measured: 10 minute electrophysiological pacing protocol

  4. Change in MCA CBF velocity in response to high right atrial pacing at 350 ms (171 bpm) relative to pacing at the lowest rate (100 bpm) while in the supine position

    Compare the MCA CBF velocity during pacing at 600 ms (100 bpm) and during pacing at 350 ms (171 bpm)

    Measured: 10 minute electrophysiological pacing protocol

  5. Change in stroke volume in response to high right atrial pacing at 400 ms (150 bpm) relative to baseline while in the supine position

    Compare the stroke volume at the participant's own baseline sinus rhythm (<100 bpm) and during pacing at 400 ms (150 bpm)

    Measured: 10 minute electrophysiological pacing protocol

  6. Change in cardiac output in response to high right atrial pacing at 400 ms (150 bpm) relative to baseline while in the supine position

    Compare the cardiac output at the participant's own baseline sinus rhythm (<100 bpm) and during pacing at 400 ms (150 bpm)

    Measured: 10 minute electrophysiological pacing protocol

  7. Change in pulse pressure in response to high right atrial pacing at 400 ms (150 bpm) relative to baseline while in the supine position

    Compare the pulse pressure at the participant's own baseline sinus rhythm (<100 bpm) and during pacing at 400 ms (150 bpm)

    Measured: 10 minute electrophysiological pacing protocol

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2020
  2. Study start11 Aug 2021
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04391465
Sponsor's protocol ID
REB20-0064
Status last verified
Apr 2026
First submitted
22 Mar 2020
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Electrophysiological Pacing in people with Cerebrovascular Circulation and Physiology, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Satish R Raj, MD MSCI (403-210-6152, satish.raj@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in MCA CBF velocity in response to high right atrial pacing at 400 ms (150 bpm) relative to baseline while in the supine position (time frame: After 1 minute of pacing at 400 ms (150 bpm)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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