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Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects (NIMO-Healthy)

Primary Purpose

Coronary Artery Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RespirAct
Sponsored by
Rohan Dharmakumar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • IU Health Methodist Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy Subjects

Arm Description

Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.

Outcomes

Primary Outcome Measures

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
Assessment of Symptom Severity and Incidence
Chest pain Headache Dizziness Confusion Fatigue Upset stomach Nausea Vomiting

Secondary Outcome Measures

Full Information

First Posted
August 3, 2023
Last Updated
August 31, 2023
Sponsor
Rohan Dharmakumar
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1. Study Identification

Unique Protocol Identification Number
NCT06000540
Brief Title
Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
October 15, 2024 (Anticipated)
Study Completion Date
October 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rohan Dharmakumar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Subjects
Arm Type
Experimental
Arm Description
Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
Intervention Type
Device
Intervention Name(s)
RespirAct
Intervention Description
RespirAct device-based computer-controlled gas delivery at different concentrations as per protocol
Primary Outcome Measure Information:
Title
Physiological Parameters Monitoring
Description
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
Time Frame
3 hours
Title
Assessment of Symptom Severity and Incidence
Description
Chest pain Headache Dizziness Confusion Fatigue Upset stomach Nausea Vomiting
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chandana Saha, PhD
Phone
317 274 0975
Email
csaha@iu.edu
Facility Information:
Facility Name
IU Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rohan Dharmakumar, PhD
Phone
317-274-0992
Email
rdkumar@iu.edu
First Name & Middle Initial & Last Name & Degree
Keyur Vora, MD MS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32096705
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.
Results Reference
result
PubMed Identifier
34687064
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.
Results Reference
result
PubMed Identifier
23204541
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.
Results Reference
result

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Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects

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