NCT04391465

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress82%
Aug 2021Jun 2027

First Submitted

Initial submission to the registry

March 22, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 11, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

4.8 years

First QC Date

March 22, 2020

Last Update Submit

May 8, 2024

Conditions

Cerebrovascular CirculationPhysiology

Keywords

Cerebral Blood Flow

Outcome Measures

Primary Outcomes (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)

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

Secondary Outcomes (7)

  • 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

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

  • 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

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

  • 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

    10 minute electrophysiological pacing protocol

  • 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

    10 minute electrophysiological pacing protocol

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

    10 minute electrophysiological pacing protocol

  • +2 more secondary outcomes

Study Arms (1)

Patients Scheduled for Elective Electrophysiological Study

EXPERIMENTAL

High 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)

Other: Electrophysiological Pacing

Interventions

Electrophysiological PacingOTHER

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

Patients Scheduled for Elective Electrophysiological Study

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Medical Center

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

Study Officials

  • Satish R Raj, MD MSCI

    University of Calgary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Satish R Raj, MD MSCI

CONTACT

403-210-6152satish.raj@ucalgary.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2020

First Posted

May 18, 2020

Study Start

August 11, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)