[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06000540":3,"trial-entities:NCT06000540":103,"trial-summary:NCT06000540":106},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":14,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":37,"secondary_outcomes":45,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":15,"eligibility_criteria":59,"std_ages":63,"locations":66,"central_contacts":85,"overall_officials":90,"references":91,"see_also_links":102},"NCT06000540","15803","Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects","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","NOT_YET_RECRUITING","2027-08-30","2026-05","2026-05-20","2026-08-01","Indiana University","OTHER",true,"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.","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.",[19],"Coronary Artery Disease",[],"INTERVENTIONAL",[23],"NA",{"count":25,"type":26},80,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","RespirAct","RespirAct device-based computer-controlled gas delivery at different concentrations as per protocol",[33,34,35,36],"Hypercapnia Group A","Hypercapnia Group B","Hypercapnia Group C","Hypoxia Group",[38,42],{"measure":39,"description":40,"timeFrame":41},"Physiological Parameters Monitoring","1. Saturation of peripheral oxygen as percentage\n2. Heart rate as beats per minute\n3. Noninvasive blood pressure as mmHg\n4. Partial pressure of oxygen as mmHg\n5. Partial pressure of carbon dioxide as mmHg","3 hours",{"measure":43,"description":44,"timeFrame":41},"Assessment of Symptom Severity and Incidence","1. Chest pain\n2. Headache\n3. Dizziness\n4. Confusion\n5. Fatigue\n6. Upset stomach\n7. Nausea\n8. Vomiting",[46,50,53],{"measure":47,"description":48,"timeFrame":49},"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",{"measure":51,"description":52,"timeFrame":41},"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.",{"measure":54,"description":55,"timeFrame":41},"Quality of Cardiac MRI","The cardiac MRI images will be assessed for quality.","ALL","45 Years",null,{"inclusion":60,"exclusion":61,"raw_text":62},[],[],"Inclusion Criteria:\n\n1. Adults ≥ 45 years of age\n2. No known cardiac disease\n\nExclusion Criteria:\n\n1. Low blood pressure (systolic blood pressure \\\u003C 100 mmHg)\n2. Inability to voluntarily increase their breathing rate if prompted to do so\n3. Persons with the inability to lie supine for 30-40 minutes\n4. Persons who are pregnant, nursing, or implanted with intrauterine devices (IUD's)\n5. Persons with significant neurological, pulmonary, renal or hepatic disease\n6. Persons who have an abnormal cardiac rhythm or resting heart rate \\>100\u002Fmin\n7. Inability or unwillingness to provide informed consent",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":68,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":82},"IU Health Methodist Hospital","Indianapolis","Indiana","46202","United States",[74,79],{"name":75,"role":76,"phone":77,"email":78},"Rohan Dharmakumar, PhD","CONTACT","317-274-0992","rdkumar@iu.edu",{"name":80,"role":81},"Keyur Vora, MD MS","SUB_INVESTIGATOR",{"lat":83,"lon":84},39.76838,-86.15804,[86],{"name":87,"role":76,"phone":88,"email":89},"Clinical Research Coordinator","317 274 0975","csaha@iu.edu",[],[92,96,99],{"pmid":93,"type":94,"citation":95},"32096705","RESULT","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\u002Fradiol.2020191456. Epub 2020 Feb 25.",{"pmid":97,"type":94,"citation":98},"34687064","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\u002Fmrm.28974. Epub 2021 Oct 22.",{"pmid":100,"type":94,"citation":101},"23204541","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\u002Fradiol.12112795. Epub 2012 Nov 30.",[],{"nct_id":4,"conditions":104,"biomarkers":105},[19],[],{"nct_id":4,"found":15,"summary":107,"prompt_version":117},{"design":108,"status":109,"heading":110,"summary":111,"follow_up":112,"word_count":113,"commitments":114,"compensation":115,"drugs_mentioned":116},"This is an interventional study, meaning participants will receive a specific intervention. It aims to enroll 80 healthy adults.","completed","Needle-Free Assessment of Myocardial Oxygenation","This study is testing a device called RespirAct to see if it can safely and effectively help identify coronary artery disease (heart disease). Researchers want to find the right levels of certain gases (high PC02 and low P02) that can act as stressors for future heart disease assessments. You may be able to join if you are an adult aged 45 or older with no known heart disease. The study will measure your body's responses (physiological parameters) and any symptoms you might have over 3 hours. The current status of this study is unclear, and it plans to enroll 80 healthy volunteers.","Your physiological parameters and symptom severity will be assessed at 3 hours after the intervention.",102,"Participants will use the RespirAct device and have their physiological parameters and symptoms monitored for 3 hours. You must be able to lie flat for 30-40 minutes.","Not stated in the trial record.",[30],"v2"]