Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects

Coronary Artery Disease Clinical Trial

— NIMO-Healthy  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06000540
• Other study ID #: 15803
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: December 15, 2024

Study information

• Verified date: April 2024
• Source: Indiana University
• Contact: Chandana Saha, PhD
• Phone: 317 274 0975
• Email: csaha[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• RespirAct
RespirAct device-based computer-controlled gas delivery at different concentrations as per protocol

Locations

Country	Name	City	State
United States	IU Health Methodist Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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 feasib — View 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. Radi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological Parameters Monitoring	Saturation of peripheral oxygen as percentage; Heart rate as beats per minute; Noninvasive blood pressure as mmHg; Partial pressure of oxygen as mmHg; Partial pressure of carbon dioxide as mmHg	3 hours
Primary	Assessment of Symptom Severity and Incidence	Chest pain; Headache; Dizziness; Confusion; Fatigue; Upset stomach; Nausea; Vomiting	3 hours
Secondary	Participant Completion	Procedure tolerability will be evaluated by the number of participants completing day 1 and day 2 of study participation.	Day 1 and Day 2
Secondary	Patient comfort level score	Participants will be asked to rate their comfort level for breathing from the mask and the gas changes as Painful, Not Comfortable, Tolerable for short time, tolerable for entire study, or comfortable.	3 hours
Secondary	Quality of Cardiac MRI	The cardiac MRI images will be assessed for quality.	3 hours