Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RespirAct.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Device RespirAct
RespirAct device-based computer-controlled gas delivery at different concentrations as per protocol
Primary outcome measures
- Physiological Parameters Monitoring [Time frame: 3 hours]
- Assessment of Symptom Severity and Incidence [Time frame: 3 hours]
Secondary outcome measures (3)
- Participant Completion [Time frame: Day 1 and Day 2]
- Patient comfort level score [Time frame: 3 hours]
- Quality of Cardiac MRI [Time frame: 3 hours]
Eligibility criteria
Inclusion criteria
- Adults ≥ 45 years of age
- No known cardiac disease
Exclusion criteria
- Low blood pressure (systolic blood pressure < 100 mmHg)
- Inability to voluntarily increase their breathing rate if prompted to do so
- Persons with the inability to lie supine for 30-40 minutes
- Persons who are pregnant, nursing, or implanted with intrauterine devices (IUD's)
- Persons with significant neurological, pulmonary, renal or hepatic disease
- Persons who have an abnormal cardiac rhythm or resting heart rate >100/min
- Inability or unwillingness to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- IU Health Methodist Hospital — Indianapolis
Publications
- 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. PMID 32096705
- 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. PMID 34687064
- 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. PMID 23204541
Identifiers
NCT: NCT06000540 · 15803