Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects

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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.

Conditions:

🦠 Coronary Artery Disease

🗓️ Study Start (Actual) 15 October 2024

🗓️ Primary Completion (Estimated) 15 October 2025

✅ Study Completion (Estimated) 30 October 2025

👥 Enrollment (Estimated) 80

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Indianapolis, Indiana, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 45 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 3 August 2023
First Submitted that Met QC Criteria 17 August 2023
First Posted 21 August 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 24 July 2024
Last Update Posted 26 July 2024
Last Verified July 2024