Clinical trial NCT06000540: Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects
Official title: A Prospective Pilot Study to Evaluate the Safety, Tolerability and Efficacy of Utilizing Precise Computer Controlled Gas Challenge in Healthy Subjects for Identification of Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 80
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a prospective pilot study to evaluate the safety, tolerability and efficacy of utilizing precise computer controlled gas challenge in healthy subjects for identification of coronary artery disease.

Detailed description: This study will establish the safe and tolerable level of high PC02 and low P02 for future studies as potential stressors for coronary artery disease assessment.

Eligibility criteria: Inclusion Criteria:

1. Adults ≥ 45 years of age
2. No known cardiac disease

Exclusion Criteria:

1. Low blood pressure (systolic blood pressure \< 100 mmHg)
2. Inability to voluntarily increase their breathing rate if prompted to do so
3. Persons with the inability to lie supine for 30-40 minutes
4. Persons who are pregnant, nursing, or implanted with intrauterine devices (IUD's)
5. Persons with significant neurological, pulmonary, renal or hepatic disease
6. Persons who have an abnormal cardiac rhythm or resting heart rate \>100/min
7. Inability or unwillingness to provide informed consent

Primary outcomes:
measure: Physiological Parameters Monitoring
timeFrame: 3 hours
measure: Assessment of Symptom Severity and Incidence
timeFrame: 3 hours
Secondary outcomes:
measure: Participant Completion
timeFrame: Day 1 and Day 2
measure: Patient comfort level score
timeFrame: 3 hours
measure: Quality of Cardiac MRI
timeFrame: 3 hours
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health Methodist Hospital
state: Indiana
Study officials:
References:
citation: Yang HJ, Dey D, Sykes J, Butler J, Biernaski H, Kovacs M, Bi X, Sharif B, Cokic I, Tang R, Slomka P, Prato FS, Dharmakumar R. Heart Rate-Independent 3D Myocardial Blood Oxygen Level-Dependent MRI at 3.0 T with Simultaneous 13N-Ammonia PET Validation. Radiology. 2020 Apr;295(1):82-93. doi: 10.1148/radiol.2020191456. Epub 2020 Feb 25.
citation: Poublanc J, Sobczyk O, Shafi R, Sayin ES, Schulman J, Duffin J, Uludag K, Wood JC, Vu C, Dharmakumar R, Fisher JA, Mikulis DJ. Perfusion MRI using endogenous deoxyhemoglobin as a contrast agent: Preliminary data. Magn Reson Med. 2021 Dec;86(6):3012-3021. doi: 10.1002/mrm.28974. Epub 2021 Oct 22.
citation: Spano VR, Mandell DM, Poublanc J, Sam K, Battisti-Charbonney A, Pucci O, Han JS, Crawley AP, Fisher JA, Mikulis DJ. CO2 blood oxygen level-dependent MR mapping of cerebrovascular reserve in a clinical population: safety, tolerability, and technical feasibility. Radiology. 2013 Feb;266(2):592-8. doi: 10.1148/radiol.12112795. Epub 2012 Nov 30.