Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-26 @ 11:41 PM
Study NCT ID:
NCT04508920
Status:
UNKNOWN
Last Update Posted:
2020-08-11
First Post:
2020-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Survey to Assess Effects of Covid-19 on Cardiovascular Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-04', 'size': 329816, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2020-08-10T15:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}, 'targetDuration': '18 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-10', 'studyFirstSubmitDate': '2020-08-07', 'studyFirstSubmitQcDate': '2020-08-10', 'lastUpdatePostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NYHA class deterioration', 'timeFrame': '1 year', 'description': 'NYHA class modification in the last four weeks. Basal and follow-up measures: Basal on June 2020. Follow up: every three months and a year (June 2021). NYHA Scale: Minimum: 1 to maximum :4'}], 'secondaryOutcomes': [{'measure': 'Dyspnea deterioration', 'timeFrame': '1 year', 'description': 'physiological parameter to worsening of shortness of breath perception, in last four weeks. Basal and follow-up measures: Basal on June 2020. Follow up: every three months and a year (June 2021).Dichotomic scale presence or absence'}, {'measure': 'Paroxysmal nocturnal dyspnea deterioration', 'timeFrame': '1 year', 'description': 'Physiological parameter to worsening of dyspnea that suddenly occurs to decubitus, in last four weeks. Basal and follow-up measures: Basal on June 2020. Follow up: every three months and a year (June 2021). Dichotomic scale presence or absence.'}, {'measure': 'Edema', 'timeFrame': '1 year', 'description': 'Physiological parameter to worsening of quantification of swollen ankles in both pelvic limbs, in last four weeks. Basal and follow-up measures: Basal on June 2020. Follow up: every three months and a year (June 2021). Dichotomic scale presence or absence'}, {'measure': 'Daily activities In the last four weeks? Please, mention if you a perceived limitation on : Walking deterioration', 'timeFrame': '1 year', 'description': 'a perceived limitation on walking more 500 meters, in last four weeks. Basal and follow-up measures: Basal on June 2020. Follow up: every three months and a year (June 2021). Dichotomic scale presence or absence.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Heart Failure']}, 'referencesModule': {'references': [{'pmid': '9043837', 'type': 'BACKGROUND', 'citation': 'Cowie MR, Mosterd A, Wood DA, Deckers JW, Poole-Wilson PA, Sutton GC, Grobbee DE. The epidemiology of heart failure. Eur Heart J. 1997 Feb;18(2):208-25. doi: 10.1093/oxfordjournals.eurheartj.a015223. No abstract available.'}, {'pmid': '24352519', 'type': 'BACKGROUND', 'citation': 'Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available.'}, {'pmid': '27206819', 'type': 'BACKGROUND', 'citation': 'Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.'}, {'pmid': '22253454', 'type': 'BACKGROUND', 'citation': 'Hawkins NM, Jhund PS, McMurray JJ, Capewell S. Heart failure and socioeconomic status: accumulating evidence of inequality. Eur J Heart Fail. 2012 Feb;14(2):138-46. doi: 10.1093/eurjhf/hfr168.'}, {'pmid': '32105632', 'type': 'BACKGROUND', 'citation': 'Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.'}, {'pmid': '32219357', 'type': 'BACKGROUND', 'citation': 'Inciardi RM, Lupi L, Zaccone G, Italia L, Raffo M, Tomasoni D, Cani DS, Cerini M, Farina D, Gavazzi E, Maroldi R, Adamo M, Ammirati E, Sinagra G, Lombardi CM, Metra M. Cardiac Involvement in a Patient With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):819-824. doi: 10.1001/jamacardio.2020.1096.'}, {'pmid': '24681044', 'type': 'RESULT', 'citation': 'Anderson JL, Heidenreich PA, Barnett PG, Creager MA, Fonarow GC, Gibbons RJ, Halperin JL, Hlatky MA, Jacobs AK, Mark DB, Masoudi FA, Peterson ED, Shaw LJ. ACC/AHA statement on cost/value methodology in clinical practice guidelines and performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures and Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jun 3;63(21):2304-22. doi: 10.1016/j.jacc.2014.03.016. Epub 2014 Mar 27. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The design included 152 patients with confirmed heart failure (HF) evaluated in two different periods of time: a baseline before the outbreak, and other during the outbreak of which 76 patients were randomized in each group. A care and follow-up guide was used as an instrument through a face-to-face survey (baseline group) and telemedicine (group outbreak). The primary outcome was the comparison of functional class modification observed in patients', 'detailedDescription': 'Population and Data Sources All patients included, confirmed diagnosis of HF, according with the ESC guidelines criteria, both genders, above 18 years, who agreed to participate. All HF outpatients belonged to an open follow-up cohort of the HF clinic of the National Institute of Cardiology of Mexico, which started enrollment since September 2016. Periodic determinations were planned, clinical, functional, therapeutic evaluations, and emotional distress. The present design is a nested comparative analysis through a care and follow-up guide to HF patients.\n\nData collection and outcomes Interventions were recorded in two groups of patients, who were randomly selected, in two different periods of time. The basal group was intervened from 15 May to 15 June 2019, a pandemic-free period. The outbreak group from 15 May to 15 June 2020, corresponding to increased activity of contagiousness and mortality associated with COVID-19, in general population in Mexico.\n\nBasal measurement was performed in a face to face method. In Outbreak period, under social isolation conditions, patients were evaluated by telephone. The assessments were performed out by medical staff with specialized training, with evaluations to which patients were accustomed by regular cohort assessments. The questions were ordered and systematized in a patient evaluation, care, and follow-up guide . A causality association question of emotional distress perception was added. Investigators recorded mortality and rehospitalization.\n\nThe primary outcome was comparison of functional class modification, secondary outcomes were Clinical alterations related to HF worsening, Therapeutic modifications, Daily physical activities, and Self-perception of health status.\n\nThe protocol conducted to hypothesize that the clinical alarm data reported by patients, in an alternative in-home model, with tele-medical assistance, is a useful tool in follow-up, as in detecting therapeutic performances, and associated with the HF deterioration.\n\nProtocol was approved by the ethics and investigational committees. All patients previously signed informed consent. Additionally, prior to the telephone survey, a verbal assent was requested. Absolute confidentiality of all patient data was declared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All HF outpatients belonged to an open follow-up cohort of the HF clinic of the National Institute of Cardiology of Mexico, which started enrollment since September 2016.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* confirmed diagnosis of HF, according with the ESC guidelines criteria\n* both genders,\n* above 18 years,\n* agreed to participate\n\nExclusion Criteria:\n\n* Impediment to contacting patients\n* marked physical impairment\n* cognitive impairment that prevents optimal interrogation\n* Cultural barriers involving communication limitation (languages, dialects, reading and writing)\n* Patient doesn't want to participate."}, 'identificationModule': {'nctId': 'NCT04508920', 'briefTitle': 'A Survey to Assess Effects of Covid-19 on Cardiovascular Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centro en Insuficiencia Cardiaca, Mexico'}, 'officialTitle': 'A Survey to Assess Effects of the Covid-19 Pandemic on Symptomatology, Treatment and Medical Care for Cardiovascular Patients', 'orgStudyIdInfo': {'id': '20-1156'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Basal', 'description': 'All adults (age \\>18 years), both gender, Heart failure patients (european society of cardiology ) criteria, sign consent.\n\nA survey to access information about symptomatology, treatment, and medical care in period may 15 to june 15, 2019 ( without covid-19 )', 'interventionNames': ['Other: Symptomatology, Treatment. daily Activities and Anxiety for Cardiovascular patients Survey (STRATA)']}, {'label': 'Ourbreak', 'description': 'All adults (age \\>18 years), both gender, Heart failure patients (european society of cardiology ) criteria, sign consent.\n\nA survey to access information about symptomatology, treatment, and medical care in period may 15 to june 15, 2020 ( ongoing covid-19 )', 'interventionNames': ['Other: Symptomatology, Treatment. daily Activities and Anxiety for Cardiovascular patients Survey (STRATA)']}], 'interventions': [{'name': 'Symptomatology, Treatment. daily Activities and Anxiety for Cardiovascular patients Survey (STRATA)', 'type': 'OTHER', 'otherNames': ['STRATA survey'], 'description': 'Interventions were recorded in two groups of patients, who were randomly selected, in two different periods of time. The basal group was intervened from 15 May to 15 June 2019, a pandemic-free period. The outbreak group from 15 May to 15 June 2020, corresponding to increased activity of contagiousness and mortality associated with COVID-19, in general population in Mexico14 Basal measurement was performed in a face to face method. In Outbreak period, under social isolation conditions, patients were evaluated by telephone. The assessments were performed out by medical staff with specialized training, with evaluations to which patients were accustomed by regular cohort assessments. The questions were ordered and systematized in a patient evaluation, care, and follow-up guide (appendix). A causality association question of emotional distress perception was added. We recorded mortality and rehospitalization', 'armGroupLabels': ['Basal', 'Ourbreak']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14080', 'city': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'CHUQUIURE-VALENZUELA EDUARDO, MD, MSc', 'role': 'CONTACT', 'email': 'echuquiurev@yahoo.com', 'phone': '+5215554017407'}, {'name': 'EDUARDO CHUQUIURE-VALENZUELA, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'ALAN FUENTES, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centro de Insuficiencia Cardiaca Instituto Nacional de Cardiologia', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'EDUARDO CHUQUIURE-VALENZUELA, MD', 'role': 'CONTACT', 'email': 'echuquiurev@yahoo.com', 'phone': '+525554017407'}, {'name': 'ALAN FUENTES-MENDOZA, MD', 'role': 'CONTACT', 'email': 'alan_fm@hotmail.com', 'phone': '+524621073512'}], 'overallOfficials': [{'name': 'EDUARDO CHUQUIURE-VALENZUELA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro en insuficiencia cardiaca'}]}, 'ipdSharingStatementModule': {'url': 'http://cardiologia.org.mx', 'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'august 1, 2021 to december 30,2021', 'ipdSharing': 'YES', 'description': 'IPD PLAN Eduardo Chuquiure-Valenzuela is Principal investigator, conceptual protocol designer, performed statistics, write manuscript and draft corrections.\n\nAlan Fuentes-Mendoza, Emmanuel Tapia-López, Daniel García-Romero Elyz Cortez-Lopez and Alejandra Marin-Sanchez, collaborate in clinical, research and analysis activities for CENTRO EN INSUFICIENCIA CARDIACA, Also, they assist in telephone interviews, writing of the manuscript. performed and checked statistics, co- writer, and draft corrections.\n\nLaura Rodríguez Chávez, Nilda Espíndola Zavaleta, Gerardo Vieyra Herrera, and Enrique Lopez Mora, are affiliated cardiologists, who participate in the draft revision for publication.', 'accessCriteria': 'open access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro en Insuficiencia Cardiaca, Mexico', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto Nacional de Cardiologia Ignacio Chavez', 'class': 'OTHER'}, {'name': 'Medica Sur Clinic & Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'EDUARDO CHUQUIURE-VALENZUELA MD MSc FACC', 'investigatorAffiliation': 'Centro en Insuficiencia Cardiaca, Mexico'}}}}