The Predictive Value of the Heart Rate Response to Breathing Maneuvers for Inducible Myocardial Perfusion Deficits

NCT05516615 | Completed DMC

• 1 other identifier: 2020-6487
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Breathing maneuvers, i.e. hyperventilation followed by breath-holding, have been shown to change coronary dynamics; hyperventilating narrows the coronary arteries, puts "stress" on the heart, and increases the heart rate, whereas breath-hold dilates the coronary arteries and decreases the heart rate," rest". Heart rate response to hyperventilation has been reported to have high diagnostic accuracy to rule out heart disease. The cardiac stress test, the modality of choice for the initial assessment of patients with suspected coronary artery disease(CAD), is routinely overprescribed by physicians, which exerts a financial burden on the healthcare system. Hence, developing an inexpensive, reliable, and available tool-HR response to breathing maneuvers- may avoid unnecessary referrals for cardiac stress tests by an effective differentiation of patients with CAD from healthy people. This study aims to assess the negative predictive value of the HR response to a 4-minute breathing maneuver for inducible myocardial ischemia, avoiding further stress testing as a gatekeeper.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Assess the negative predictive value of the heart rate acceleration in response to 1-min hyperventilation

  To rule out the presence of inducible myocardial perfusion deficit in patients with suspected coronary artery disease compared to healthy volunteers A ROC analysis will provide an optimal cut-point value for the level of heart rate acceleration in response to 1-min hyperventilation to identify its ability to rule out myocardial perfusion deficit

  June 2020 - August 2021

• To assess the negative predictive value of the heart rate recovery in response to maximal voluntary breath-hold

  To rule out the presence of inducible myocardial perfusion deficit in patients with suspected coronary artery disease compared to healthy volunteers A ROC analysis will provide an optimal cut-point value for the level of heart rate recovery in response to maximal voluntary breath-hold to identify its ability to rule out myocardial perfusion deficit

  June 2020 - August 2021

Secondary Outcomes (2)

• To assess the negative predictive value of heart rate variability during 4-min breathing maneuver to rule out the presence of inducible myocardial perfusion deficit in patients with suspected coronary artery disease compared to healthy volunteers

  June 2020 - August 2021

• To assess the negative predictive value of the combination of INTERHEART risk score and HR response to breathing maneuver to rule out the presence of inducible myocardial perfusion deficit

  June 2020 - August 2021

Other Outcomes (2)

• To compare the myocardial oxygenation changes in OS-CMR images between healthy volunteers and patients with suspected or known CAD

  June 2020 - August 2021

• To assess the relationship between myocardial oxygenation changes in OS-CMR images with perfusion deficit in adenosine stress first-pass perfusion MRI

  June 2020 - August 2021

Study Arms (2)

Healthy volunteers

1. Aged more than 35 2. No known current or pre-existing problems that would affect the cardiovascular or respiratory system

Other: 4 minute breathing maneuver

Patient population

1. Aged more than 35 2. Referral of subjects with known or suspected CAD for adenosine stress first-pass perfusion MRI based on the clinical judgement of their referring physician

Other: 4 minute breathing maneuver

Interventions

4 minute breathing maneuver OTHER

The 4-minute breathing maneuver comprised of 2 minutes of normal breathing and 1-min hyperventilation (rate of 30 breaths or more per minute) followed by a maximal breath-hold.

Healthy volunteers; Patient population

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy volunteers and patients with known or suspected Coronary Artery Disease (CAD) aged more than 35.

You may qualify if:

• Healthy volunteers:
• Aged \> 35
• No known current or pre-existing problems that would affect the cardiovascular or respiratory system
• Patient population:
• Aged \> 35
• Clinically indicated referral for adenosine stress first-pass perfusion MRI in subjects with known or suspected coronary artery disease

You may not qualify if:

• Healthy Volunteers:
• MR incompatible devices such as pacemakers, defibrillators, implanted material, or foreign bodies.
• Consumption of caffeine (coffee, tea, cocoa, chocolate, "energy drink") during the 12 hours prior to the exam
• Presence of cardiovascular disease.
• Regular nicotine consumption during the last 6 months
• Patient Population:
• MR incompatible devices such as pacemakers, defibrillators, implanted material, or foreign bodies.
• Vasoactive medication (e.g. nitrate, beta-blocker, calcium channel blocker) during the 12 hours prior to the exam.
• Consumption of caffeine (coffee, tea, cocoa, chocolate, "energy drink") during the 12 hours prior to the exam
• Acute Coronary Syndrome (ACS), or previous Coronary Artery Bypass Surgery
• Previous myocardial infarction within one month
• Clinically unstable condition
• Significant or uncontrolled arrhythmia
• Patients who are pregnant
• Active myocarditis, constrictive pericarditis, any cardiomyopathy, cardiac or systemic amyloidosis

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

The Research Institute of the McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: July 14, 2020
• Primary Completion: April 18, 2023
• Study Completion: April 18, 2023
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)