Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT06332456
Status:
COMPLETED
Last Update Posted:
2025-07-29
First Post:
2024-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Renal Microcirculation With Rubidium Positron Emission Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2024-03-14', 'studyFirstSubmitQcDate': '2024-03-20', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal blood flow in units of mL/min/100g', 'timeFrame': '1 day', 'description': 'Average difference of RBF between healthy controls and CKD participants'}], 'secondaryOutcomes': [{'measure': 'Renal vascular resistance in units of mmHg/mL/min/100g', 'timeFrame': '1 day', 'description': 'Average difference of RVR between healthy controls and CKD participants'}, {'measure': 'Correlation between renal vascular resistance measured with PET and measured with echography', 'timeFrame': 'Up to 4 weeks', 'description': 'Correlation coefficient between RBF vs echographic measurements of renal RI'}, {'measure': 'Coefficient of repeatability of renal blood flow', 'timeFrame': '1 day', 'description': 'Coefficient of repeatability, coefficient of variation, and correlation between repeated measurements'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Microcirculation With Rubidium Positron Emission Tomography']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to demonstrate that positron emission tomography imaging with Rubidium-82 (radioactive tracer) can non-invasively detect and quantify changes in renal blood flow (renal perfusion) and renal vascular resistance in both healthy subjects and patients with renal insufficiency. Ultimately, the results of this study will contribute to a better understanding of the role of positron emission imaging in the evaluation of patients with renal diseases.', 'detailedDescription': '2\\. Hypothesis\n\n1. We hypothesize that RBF assessed with rubidium PET is on average lower in patients with CKD. To test our hypothesis, RBF of patients with CKD and coronary artery disease (CAD) risk factors, a population characterized by renal microvascular rarefaction, will be compared to RBF of healthy controls.\n2. We hypothesize that RVR assessed with rubidium PET correlates with echographic measurements of renal resistance index (RI), the current non-invasive method of choice.\n3. We hypothesize that RBF quantification with rubidium PET is technically reproducible, meaning that the variation on the measurements of RBF purely attributable to technical factors (camera, positioning, tracer injection, etc.) is relatively small. To test this hypothesis, two PET scans will be acquired within a short time period.\n\n3\\. Objectives and Endpoints 3.1. Primary Objective\n\n1\\) To compare RBF of patients with CKD and CAD risk factors to healthy controls 3.2. Secondary Objectives\n\n1. To compare RVR of patients with CKD and CAD risk factors to healthy controls\n2. To evaluate the correlation between RVR measured with PET to renal RI as measured with echography\n3. To evaluate the repeatability and reproducibility of in vivo measurements of RBF and RVR'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. 15 healthy volunteers\n2. 15 patients with CKD and CAD risk factors with GFR between 30 and 45 mL/min/1.73m2 from HFpEF clinic at ICM', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nControl Group\n\n1. Age ≥ 18 years and \\< 80 years\n2. Signed informed consent\n3. No medical history of renal disease\n\nCKD Group\n\n1. Age ≥ 18 years and \\< 80 years\n2. Signed informed consent\n3. GFR between 30 and 45 mL/min/1.73m2 measured within the last 3 months\n4. At least two cardiovascular disease risk factors such as hypertension, smoking, diabetes, obesity, and dyslipidemia\n\nExclusion Criteria:\n\nControl Group\n\n1. Hypertension\n2. Diabetes\n3. Dyslipidemia\n4. Active smoking within the last 12 month\n5. Left ventricular ejection fraction \\<45%\n6. BMI \\>45 kg/m2\n7. Severe aortic stenosis\n\nCKD Group\n\n1. Left ventricular ejection fraction \\<45%\n2. BMI \\>45 kg/m2\n3. Severe aortic stenosis\n4. Changes in medical therapy within the last 4 weeks\n5. Documented renal artery stenosis\n6. Known structural cause of CKD including polycystic kidney disease, obstruction, or other post-renal causes\n7. Pregnancy or breastfeeding\n8. Renal failure requiring dialysis within the last 90 days'}, 'identificationModule': {'nctId': 'NCT06332456', 'acronym': 'RESIST', 'briefTitle': 'Assessment of Renal Microcirculation With Rubidium Positron Emission Tomography', 'organization': {'class': 'OTHER', 'fullName': 'Montreal Heart Institute'}, 'officialTitle': 'Assessment of Renal Microcirculation With Rubidium Positron Emission Tomography: A Proof-of-Concept Study', 'orgStudyIdInfo': {'id': 'ICM 2023-3169'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': '15 healthy volunteers'}, {'label': 'CKD', 'description': '15 patients with CKD and CAD risk factors with GFR between 30 and 45 mL/min/1.73m2'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Matthieu Pelletier-Galarneau, MD MSc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD MSc', 'investigatorFullName': 'Matthieu Pelletier-Galarneau, MD MSc', 'investigatorAffiliation': 'Montreal Heart Institute'}}}}