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Heart Rate Control for Cerebrovascular Physiology

N/A

Recruiting

Led By Satish R Raj, MD MSCI

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-70 years, inclusive

Scheduled for clinically indicated elective electrophysiological studies where temporary pacing catheters are being placed in the right atrium

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 1 minute of pacing at 600 ms (100 bpm)

Awards & highlights

Study Summary

This trial will investigate the link between heart rate and blood flow to the middle cerebral artery, as well as the factors that affect blood flow velocity in this artery. Patients already scheduled for heart-related procedures will be recruited, and their heart rate will be artificially controlled using pacing catheters. Blood flow in the middle cerebral artery will be monitored using transcranial Doppler ultrasound.

Who is the study for?

This trial is for adults aged 18-70 with a healthy heart pump function, scheduled for elective heart rhythm studies where they'll get temporary pacing wires in the right atrium. Participants must consent to the study and be able to visit the Cardiac Electrophysiology Lab in Calgary, Canada.Check my eligibility

What is being tested?

The study aims to understand how different heart rates affect blood flow in a brain artery by using controlled electrical stimulation of the heart during routine electrophysiological procedures and measuring blood flow with an ultrasound on the head.See study design

What are the potential side effects?

Since this trial involves standard clinical procedures, side effects may include discomfort from pacing catheter placement and potential risks associated with transcranial Doppler ultrasound like minor pain or bruising at sensor sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I am scheduled for a heart rhythm test that involves placing pacing wires in the right side of my heart.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 1 minute of pacing at 350 ms (171 bpm)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 1 minute of pacing at 350 ms (171 bpm)

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 1 minute of pacing at 350 ms (171 bpm) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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

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

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients Scheduled for Elective Electrophysiological StudyExperimental Treatment1 Intervention

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)

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,134 Total Patients Enrolled

Satish R Raj, MD MSCIPrincipal InvestigatorUniversity of Calgary

19 Previous Clinical Trials

1,406 Total Patients Enrolled

Media Library

Electrophysiological Pacing Clinical Trial Eligibility Overview. Trial Name: NCT04391465 — N/A

Cerebrovascular Disease Clinical Trial 2023: Electrophysiological Pacing Highlights & Side Effects. Trial Name: NCT04391465 — N/A

Electrophysiological Pacing 2023 Treatment Timeline for Medical Study. Trial Name: NCT04391465 — N/A

Cerebrovascular Disease Research Study Groups: Patients Scheduled for Elective Electrophysiological Study

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are contributing to this research effort?

"Affirmative. According to the clinicaltrials.gov page, this medical study is actively recruiting patients; it was first posted on August 11th 2021 and modified most recently on September 28th of the same year. The experiment requires 20 volunteers sourced from a single centre."

Answered by AI

Is enrollment open for this trial?

"Confirmed. Clinicaltrials.gov provides evidence that this trial, initially posted on August 11th 2021, is still recruiting patients. 20 participants are required from 1 medical facility for the study to be completed successfully."

Answered by AI

Who meets the criteria for participating in this experiment?

"This medical research is recruiting 20 test subjects aged between 18 and 70 years old. Eligibility requirements include being a man or woman, within the specified age range."

Answered by AI

Does eligibility for this medical study extend to people younger than sixty years of age?

"Those wishing to be considered for this trial must fall between the age bracket of 18 and 70. For those younger than 18 or older than 65, there are 1 and 2 respective trials which they may qualify for."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Assessment of the Relationship Between Cerebral Blood Flow and Heart Rate

2021. "Assessment of the Relationship Between Cerebral Blood Flow and Heart Rate". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04391465.