[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04843371":3,"trial-entities:NCT04843371":139,"trial-summary:NCT04843371":146},{"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":22,"study_type":26,"primary_purpose":15,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":42,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":61,"locations":64,"central_contacts":104,"overall_officials":107,"references":109,"see_also_links":138},"NCT04843371","2021-441","PPG to Predict Ejection Fraction and Other Echographic Data in the General Population","Photoplethysmography (PPG) to Predict Ejection Fraction and Other Echographic Data in the General Population","RECRUITING","2026-12","2026-03","2026-03-05","2021-08-20","Tulane University","OTHER",null,"The investigators are aiming to investigate the association between ejection fraction (EF) determined by echocardiography and signals obtained from Photoplethysmography (PPG) in the general population. The investigators are also aiming to investigate the association between blood pressure and signals obtained from PPG in the general population.\n\nFinally, the investigators are also aiming to investigate the association between signals obtained from PPG in the general population to cardioechographic findings such as, valvular heart disease, structural heart diseases, cardiomyopathies, pericardial disease etc.","The investigators are proposing a cross-sectional cohort study, where any individual, 18 years old or older, scheduled for an echocardiography at Tulane University's outpatient cardiology clinic can be included. After consenting participants, information on their demographics, personal health habits, medications, and medical history will be collected via reviewing, their electronic medical health records. All participants will undergo an echocardiography as part of their routine medical care by their treating physician. Important echocardiographic findings will be noted such as, EF, valvular heart disease, pericardial disease, cardiomyopathies and structural heart disease. Additionally, PPG recordings will be collected simultaneously while performing echography using the Biostrap wristband.\n\nThe investigators will analyze the association between each echographic imaging feature, and the PPG waveform obtained. PPG waveform features will be used to develop a predictive model capable of calculating an estimate of ventricular ejection fraction without echocardiography. All echocardiograms will be performed by experienced operators at Tulane Medical Center facilities. The study will occur at a single study site Tulane Medical Center and clinics, with appropriate facilities and equipment to conduct the study accurately and safely.\n\nAn experienced echocardiogram technician or cardiology fellow will collect the PPG recordings using the Biostrap application. De-identified echocardiogram reports, including information on LVEF will be matched with the participant's pulse report.",[19,20,21],"Valvular Heart Disease","Pericardial Disease","Cardiomyopathies",[23,24,25],"Structural heart disease","Photoplethysmography","Ejection Fraction","OBSERVATIONAL",[],{"count":29,"type":30},500,"ESTIMATED",[32],{"type":33,"name":24,"description":34,"armGroupLabels":35},"DIAGNOSTIC_TEST","Photoplethysmography (PPG) is a non-invasive technique that can detect volumetric changes in the peripheral blood. It only requires skin contact and relies on light absorption. PPG is a good indicator of the cardiovascular dynamics in the human body. PPG has been incorporated into various new smartphones and wearable devices such as, smartwatches and fitness wristbands making it readily available to all consumers. This sensor can record biometrics such as, heart rate, blood pressure, oxygen saturation, etc.",[36],"Patient Group",[38],{"measure":39,"description":40,"timeFrame":41},"Association between obtained PPG waveforms and recorded ejection (EF) fractions.","Patients who will undergo echocardiogram will wear the biostrap watch and then the PPG waveform will be obtained. Then, the ejection fraction will be collected from the echocardiogram report. Then, the Artificial Intelligence (AI) staff member will do a predictive model to try and estimate the EF based on the PPG waveform.","Day 1",[43],{"measure":44,"description":45,"timeFrame":46},"Association between blood pressure and PPG waveforms","The investigators will record the blood pressure of the patient twice during their visit. Then, the Artificial Intelligence (AI) staff member will do a predictive model to try and estimate the blood pressure based on the PPG waveform.","Day1","ALL","18 Years","120 Years",true,{"inclusion":52,"exclusion":55,"raw_text":60},[53,54],"Male or Female aged18 years or older.","Patients scheduled to undergo an echocardiogram at Tulane Medical Center.",[56,57,58,59],"Participants under 18 years of age.","Participants with cognitive impairments.","Participants with a physical inability to wear the Biostrap during the echocardiogram.","Individuals who cannot read, speak, and\u002For understand English.","Inclusion Criteria:\n\n* Male or Female aged18 years or older.\n* Patients scheduled to undergo an echocardiogram at Tulane Medical Center.\n\nExclusion Criteria:\n\n* Participants under 18 years of age.\n* Participants with cognitive impairments.\n* Participants with a physical inability to wear the Biostrap during the echocardiogram.\n* Individuals who cannot read, speak, and\u002For understand English.",[62,63],"ADULT","OLDER_ADULT",[65,87,96],{"facility":66,"status":8,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":84},"East Jefferson General Hospital","New Orleans","Louisiana","70006","United States",[72,77,81],{"name":73,"role":74,"phone":75,"email":76},"Mayana Bsoul, MD","CONTACT","504-988-3063","mbsoul@tulane.edu",{"name":78,"role":74,"phone":79,"email":80},"Kunal Sameer, MD, MHA","504-988-3072","ksameer@tulane.edu",{"name":82,"role":83},"Nassir Marrouche, MD","PRINCIPAL_INVESTIGATOR",{"lat":85,"lon":86},29.95465,-90.07507,{"facility":88,"status":8,"city":67,"state":68,"zip":89,"country":70,"contacts":90,"geoPoint":95},"University Medical Center","70112",[91,93,94],{"name":73,"role":74,"phone":75,"email":92},"mbsoulmbsoul@tulane.edu",{"name":78,"role":74,"phone":79,"email":80},{"name":82,"role":83},{"lat":85,"lon":86},{"facility":97,"status":8,"city":67,"state":68,"zip":98,"country":70,"contacts":99,"geoPoint":103},"Tulane Doctors - Speciality Care - Napoleon","70115",[100,101,102],{"name":73,"role":74,"phone":75,"email":76},{"name":78,"role":74,"phone":79,"email":80},{"name":82,"role":83},{"lat":85,"lon":86},[105,106],{"name":73,"role":74,"phone":75,"email":76},{"name":78,"role":74,"phone":79,"email":80},[108],{"name":82,"affiliation":13,"role":83},[110,114,117,120,123,126,129,132,135],{"pmid":111,"type":112,"citation":113},"18772638","BACKGROUND","McDonagh TA, McDonald K, Maisel AS. Screening for asymptomatic left ventricular dysfunction using B-type natriuretic Peptide. Congest Heart Fail. 2008 Jul-Aug;14(4 Suppl 1):5-8. doi: 10.1111\u002Fj.1751-7133.2008.tb00002.x.",{"pmid":115,"type":112,"citation":116},"11356434","Dargie HJ. Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial. Lancet. 2001 May 5;357(9266):1385-90. doi: 10.1016\u002Fs0140-6736(00)04560-8.",{"pmid":118,"type":112,"citation":119},"26320108","Priori SG, Blomstrom-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliott PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekval TM, Spaulding C, Van Veldhuisen DJ; ESC Scientific Document Group. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J. 2015 Nov 1;36(41):2793-2867. doi: 10.1093\u002Feurheartj\u002Fehv316. Epub 2015 Aug 29. No abstract available.",{"pmid":121,"type":112,"citation":122},"19477397","Betti I, Castelli G, Barchielli A, Beligni C, Boscherini V, De Luca L, Messeri G, Gheorghiade M, Maisel A, Zuppiroli A. The role of N-terminal PRO-brain natriuretic peptide and echocardiography for screening asymptomatic left ventricular dysfunction in a population at high risk for heart failure. The PROBE-HF study. J Card Fail. 2009 Jun;15(5):377-84. doi: 10.1016\u002Fj.cardfail.2008.12.002. Epub 2009 Jan 21.",{"pmid":124,"type":112,"citation":125},"15184280","Redfield MM, Rodeheffer RJ, Jacobsen SJ, Mahoney DW, Bailey KR, Burnett JC Jr. Plasma brain natriuretic peptide to detect preclinical ventricular systolic or diastolic dysfunction: a community-based study. Circulation. 2004 Jun 29;109(25):3176-81. doi: 10.1161\u002F01.CIR.0000130845.38133.8F. Epub 2004 Jun 7.",{"pmid":127,"type":112,"citation":128},"26649910","Blanie A, Soued M, Benhamou D, Mazoit JX, Duranteau J. A Comparison of Photoplethysmography Versus Esophageal Doppler for the Assessment of Cardiac Index During Major Noncardiac Surgery. Anesth Analg. 2016 Feb;122(2):430-6. doi: 10.1213\u002FANE.0000000000001113.",{"pmid":130,"type":112,"citation":131},"17395998","Chan GS, Middleton PM, Celler BG, Wang L, Lovell NH. Automatic detection of left ventricular ejection time from a finger photoplethysmographic pulse oximetry waveform: comparison with Doppler aortic measurement. Physiol Meas. 2007 Apr;28(4):439-52. doi: 10.1088\u002F0967-3334\u002F28\u002F4\u002F009. Epub 2007 Mar 20.",{"pmid":133,"type":112,"citation":134},"19170720","Middleton PM, Chan GS, O'Lone E, Steel E, Carroll R, Celler BG, Lovell NH. Changes in left ventricular ejection time and pulse transit time derived from finger photoplethysmogram and electrocardiogram during moderate haemorrhage. Clin Physiol Funct Imaging. 2009 May;29(3):163-9. doi: 10.1111\u002Fj.1475-097X.2008.00843.x. Epub 2009 Jan 22.",{"pmid":136,"type":112,"citation":137},"32999400","Nachman D, Gepner Y, Goldstein N, Kabakov E, Ishay AB, Littman R, Azmon Y, Jaffe E, Eisenkraft A. Comparing blood pressure measurements between a photoplethysmography-based and a standard cuff-based manometry device. Sci Rep. 2020 Sep 30;10(1):16116. doi: 10.1038\u002Fs41598-020-73172-3.",[],{"nct_id":4,"conditions":140,"biomarkers":145},[141,142,143,144],"Cardiomyopathy","Perianal disease","Structural Heart Disease","Valvular Heart Disorder",[],{"nct_id":4,"found":50,"summary":147,"prompt_version":157},{"design":148,"status":149,"heading":150,"summary":151,"follow_up":152,"word_count":153,"commitments":154,"compensation":155,"drugs_mentioned":156},"This is an observational study planning to include 500 participants. It is a cross-sectional study, meaning data is collected at a single point in time.","completed","Observational Study of PPG and Heart Health","This study is looking at how a non-invasive test called Photoplethysmography (PPG) relates to heart health information gathered from an echocardiogram (a type of heart ultrasound). Researchers want to see if PPG, which uses light to detect changes in blood flow, can help predict things like ejection fraction (how well your heart pumps blood) and identify conditions like valvular heart disease or cardiomyopathies (heart muscle diseases). You might be able to join if you are 18 or older and are already scheduled for an echocardiogram at Tulane Medical Center. The main goal is to find a connection between PPG readings and your ejection fraction on the day of your echocardiogram. The current status of this study is unclear.","The primary endpoint, the association between PPG waveforms and ejection fraction, is measured at Day 1, indicating a short follow-up period.",118,"If you participate, your demographic, health habits, medications, and medical history will be collected from your electronic medical records. You will undergo an echocardiogram as part of your routine care, and PPG recordings will be taken at the same time using a wristband.","Not stated in the trial record.",[24],"v2"]