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NCT Number: NCT06253884

Utilizing Carbon Dioxide for Assessing Coronary Blood Flow in Subjects With Coronary Artery Disease

This is a prospective pilot study to evaluate the safety, tolerability and technical feasibility of utilizing carbon dioxide for assessing coronary blood flow in subjects with coronary artery disease.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location contact

Keyur Vora, MD MS

SUB_INVESTIGATOR

Rohan Dharmakumar, PhD

CONTACT

[email protected]

317-274-0992

About this study

The purpose of this study is to noninvasively assess changes in the heart's blood flow through inducing changes in the amount of carbon dioxide in the participant's blood and having them breathe various combinations of carbon dioxide and oxygen.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults > 18 years of age
  • Clinically stable individuals with suspected or known coronary artery disease (CAD)
  • The SPECT/PET study indicates at least a mild to moderate myocardial ischemia (>5-9%) or fractional-flow-reserve (FFR) of <0.75.

Exclusion criteria

  • Prior myocardial infarction by clinical history (subjects with prior coronary revascularization without myocardial infarction will not be excluded)
  • Hypotension (systolic blood pressure < 100 mmHg)
  • Significant non-coronary cardiac disease (e.g., valvular abnormality, or cardiomyopathy, etc.)
  • Inability to schedule the research study within 30 days of the SPECT/PET study and prior to any coronary revascularization procedure
  • Inability to voluntarily increase their breathing rate if prompted to do so
  • Persons with mechanically, magnetically, or electrically activated implants (such as cardiac pacemakers, neurostimulators, and infusion pumps), with ferromagnetic implants or foreign bodies (such as intracranial, aneurysm clips, shrapnel, and intraocular metal chips)
  • Persons who are pregnant, nursing, or implanted with intrauterine devices (IUD's)
  • Persons with a history of significant heart, lung, kidney, or liver disease
  • Persons with asthma
  • Persons who have abnormal cardiac rhythm and rate
  • Persons unable to tolerate MRI secondary to an inability to lie supine for 60-90 minutes or severe claustrophobia
  • Persons whose renal function test does not meet MRI contrast protocol requirements [estimated Glomerular filtration rate (eGFR) < 40 mL/min/1.73m2]
  • Persons with a known history of allergy to gadolinium-based contrast
  • Enrollment in another research study.
  • Inability or unwillingness to provide informed consent

Treatment and study plan

RespirAct

Device

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

Primary outcomes

  1. Ratio of Maximum Signal Intensity (MSI) by BOLD MRI

    Time frame: 3 hours

    Maximum Signal Intensity (MSI) quantification will be measured through myocardial perfusion by blood oxygen level dependent (BOLD) MRI. The ratio of MSI in hypercarbia vs normocarbia will be evaluated in the 17-segment LV model.

  2. Ratio of Maximum Signal Intensity (MSI) by FFP MRI

    Time frame: 3 hours

    Maximum Signal Intensity (MSI) quantification will be measured through myocardial perfusion by first pass perfusion (FFP) MRI. The ratio of MSI in hypercarbia vs normocarbia will be evaluated in the 17-segment LV model.

Study contacts

Contact information is provided by the study sponsor or research team.

Chandana Saha, PhD

CONTACT

[email protected]

317 274 0975

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

A Prospective Pilot Study to Evaluate the Safety, Tolerability and Technical Feasibility of Utilizing Carbon Dioxide (CO2) for Assessing Coronary Blood Flow in Subjects With Coronary Artery Disease

Acronym: NIMO-CAD

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2024
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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