Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-03-14 @ 5:47 AM
Study NCT ID:
NCT03450304
Status:
UNKNOWN
Last Update Posted:
2018-03-02
First Post:
2018-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Perfusion Measured With Dual-Energy CT in Patients With Chronic Thromboembolic Pulmonary Hypertension: Comparative Study With Right Heart Catheterization and V/Q
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-10-04', 'releaseDate': '2019-09-16'}, {'resetDate': '2019-11-14', 'releaseDate': '2019-10-27'}, {'resetDate': '2019-12-12', 'releaseDate': '2019-11-25'}, {'resetDate': '2019-12-31', 'releaseDate': '2019-12-12'}], 'estimatedResultsFirstSubmitDate': '2019-09-16'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-28', 'studyFirstSubmitDate': '2018-02-22', 'studyFirstSubmitQcDate': '2018-02-27', 'lastUpdatePostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung perfusion measured with Dual-Energy CT (DECT) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH)', 'timeFrame': 'cross-sectional (one measurement). The minimum sample size calculated is 26 patients, which with the amount of patients handled in the pulmonary hypertension clinic at our institution is expect to reach in 16 months or before through study completion', 'description': 'The objective is to evaluate lung perfusion quantification by DECT in patients with Chronic Thromboembolic Pulmonary Hypertension and compare findings with digital subtraction angiography with right heart catheterization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multidetector Computed Tomography', 'Pulmonary Embolism', 'Hypertension Pulmonary Secondary'], 'conditions': ['Multidetector Computed Tomography', 'Pulmonary Embolism and Thrombosis', 'Hypertension Pulmonary Secondary']}, 'descriptionModule': {'briefSummary': 'A comparative, observational, cross-sectional and prolective diagnostic test study, including patients that have had a right heart catheterization and were referred for a CT pulmonary angiography as part of their imaging workup protocol for pulmonary hypertension.\n\nDual-energy computed tomography (DECT) pulmonary angiography was performed on each patient to obtain perfusion maps and do a quantitative analysis. Segments with and without perfusion defects according to significant differences in the quantitative values, were defined as compatible or not with chronic thromboembolism.\n\nTo assess the accuracy of the method and evaluate its performance, these results were compared with the sole results from the right heart catheterization, known to be the gold standard diagnostic tool.', 'detailedDescription': 'a comparative, observational, cross-sectional and prolective diagnostic test study is conducted, including consecutive patients from the pulmonary hypertension clinic at our institution, from March 2017 to October 2018. Patients that have had a right heart catheterization and were referred for a CT pulmonary angiography as part of their imaging workup protocol. (The minimum sample size calculated is 26 patients).\n\nDECT pulmonary angiography (256-slice and double-source CT scanner) was performed on each patient. Obtaining perfusion maps and doing a quantitative analysis by circular regions of interest (ROI) and iodine-related attenuation values (IRA) on each lung segment. Then, according to the finding in right heart catheterization, a comparison will be made between to groups: segments with and without perfusion defects, in order to find significant differences in the quantitative.\n\nTo assess the accuracy of the method and evaluate its performance, these results were later compared with the sole results from the right heart catheterization.\n\nROC curves were plotted to extract possible decision thresholds of the IRA values to classify perfusion as normal or deficient with this technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients from the pulmonary hypertension clinic at our institution, from July 2017 to October 2018', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients from the pulmonary hypertension clinic at our institution who have had right heart catheterization and were referred for a pulmonary CT angiography as part of their imaging workup protocol.\n\nExclusion Criteria:\n\n* creatinine \\> 1.5 mg/dL'}, 'identificationModule': {'nctId': 'NCT03450304', 'briefTitle': 'Lung Perfusion Measured With Dual-Energy CT in Patients With Chronic Thromboembolic Pulmonary Hypertension: Comparative Study With Right Heart Catheterization and V/Q', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Cardiologia Ignacio Chavez'}, 'officialTitle': 'Lung Perfusion Measured With Dual-Energy CT (DECT) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH): Comparative Study With Right Heart Catheterization and Ventilation/Perfusion Scintigraphy (V/Q)', 'orgStudyIdInfo': {'id': 'PT-17-050'}}, 'contactsLocationsModule': {'locations': [{'city': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Tomas Zamudio Pulido, Dr', 'role': 'CONTACT', 'email': 'pulidot@me.com', 'phone': '+525551002561'}], 'facility': 'Instituto Nacional de Cardiología Dr. Ignacio Chávez', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Cesar Cristancho Rojas, physician', 'role': 'CONTACT', 'email': 'cncr777@hotmail.com', 'phone': '+525566119048'}, {'name': 'Tomas Pulido Zamudio, Doctor', 'role': 'CONTACT', 'email': 'pulidot@me.com', 'phone': '+525554242597'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'by request by mail'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Cardiologia Ignacio Chavez', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sergio Criales Vera', 'class': 'UNKNOWN'}, {'name': 'Mariana Díaz Zamudio', 'class': 'UNKNOWN'}, {'name': 'Nayeli Zayas Hernández', 'class': 'UNKNOWN'}, {'name': 'Eric Kimura Hayama', 'class': 'UNKNOWN'}, {'name': 'Regina De La Mora', 'class': 'UNKNOWN'}, {'name': 'Tomás Pulido Zamudio', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'César Cristancho rojas', 'investigatorAffiliation': 'Instituto Nacional de Cardiologia Ignacio Chavez'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-09-16', 'type': 'RELEASE'}, {'date': '2019-10-04', 'type': 'RESET'}, {'date': '2019-10-27', 'type': 'RELEASE'}, {'date': '2019-11-14', 'type': 'RESET'}, {'date': '2019-11-25', 'type': 'RELEASE'}, {'date': '2019-12-12', 'type': 'RESET'}, {'date': '2019-12-12', 'type': 'RELEASE'}, {'date': '2019-12-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'César Cristancho rojas, Resident, Instituto Nacional de Cardiologia Ignacio Chavez'}}}}