CARTIZ Registry: Cartilage, Arthropathy and Imaging Under Tirzepatide in Zone-stratified Cohorts - A Four-Institute Mexican Observational Registry

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan mexikói felnőtteket keres, akik már orvosi okból tirzepatidot szednek, és ízületi problémájuk van, például pikkelysömörös ízületi gyulladás vagy térdartrózis.

Életkor

18 éves vagy idősebb

Nem

Minden nem

A betegség stádiuma

Legalább egy dokumentált ízületi probléma, jelenlegi vagy korábbi: gyulladásos ízületi fájdalom, pikkelysömörös ízületi gyulladás, röntgennel igazolt térdartrózis, enthesitis vagy szakorvos által megállapított gyulladásos ízületi betegség.

Korábbi kezelés

Jelenleg a saját orvosa által felírt tirzepatidot szedi, és legalább 52 hétig folytatni tervezi. Az ízületi állapotról a tirzepatid kezdete előtti dokumentációnak elérhetőnek kell lennie.

A részvétel fő kizáró okai

• Biológiai DMARD vagy JAK-gátló kezdése vagy módosítása a 0. hetet megelőző 12 hétben
• Nagy ízületi műtét az elmúlt 3 hónapban, vagy tervezett műtét a következő 12 hónapban
• Kortikoszteroid vagy hialuronsav ízületi injekció az elmúlt 6 hétben
• Aktív daganatos betegség (kezelt nem melanóma típusú bőrrák kivételével)
• Terhesség, szoptatás vagy tervezett terhesség; vagy olyan eszköz, amely kizárja az MRI-vizsgálatot

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

CARTIZ is a prospective observational clinical registry of adults in Mexico receiving tirzepatide (a dual GLP-1/GIP receptor agonist) under an independent clinical indication - typically type 2 diabetes, insulin resistance, obesity, renal protection, metabolic hypertension, or associated off-label metabolic use. The registry is entirely observational: CARTIZ does not initiate, modify, interrupt, or supply tirzepatide, and does not dictate dose, route, or duration. All pharmacological exposure decisions are made by the treating physician independently of study participation. The registry is operationalized through a four-institute architecture integrating three Mexican National Institutes of Health and one national imaging laboratory. Core 1 (Knee Cartilage Imaging, Ci3M UAM-Iztapalapa) performs bilateral 3T MRI with quantitative T2 mapping at Week 0 and Week 52. Core 2 (Cardiac Imaging, Instituto Nacional de Cardiología Ignacio Chávez) performs non-contrast cardiac computed tomography for radiomic phenotyping of epicardial adipose tissue at Week 0 and Week 52 under cardiovascular Co-Principal Investigator Dr. Erick Alexánderson Rosas. Core 3 (HLA Typing, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Transplant Department) performs Class I and Class II HLA typing by PCR-SSO Reverse Luminex. Core 4 (Body Composition, Universidad La Salle México) performs multi-frequency bioelectrical impedance analysis (seca mBCA) at six longitudinal timepoints capturing visceral adipose tissue trajectory, phase-angle trajectory, appendicular skeletal muscle mass, and hydration ratios at zero marginal cost. The registry enrolls n=30 patients across three clinical sites with identical protocol (IMSS Clínica Río Magdalena, INCMNSZ outpatient clinic, and a private practice site in Mexico City), generating 60 evaluable knees and 30 paired cardiac CT studies. The primary co-endpoints address a mechanistic question no other tirzepatide study is positioned to answer: whether the articular response to tirzepatide in inflammatory arthropathy precedes and mechanistically precedes weight loss, through formal mediation analysis of Week-4 ACR20 response via high-sensitivity C-reactive protein, SERPINB2, and dipeptidyl peptidase-4 activity, restricted to the Mechanistic Analysis Set of patients with tirzepatide exposure ≤16 weeks at Week 0 and delta-BMI <1.0 kg/m² through Week 4. A prespecified Surgical Tissue Subcohort is declared at initial registration to establish public scientific priority on direct human epicardial adipose tissue transcriptomic characterization under dual GIP/GLP-1 receptor agonism. Subcohort participants who undergo clinically indicated cardiac surgery at INCar during follow-up (coronary artery bypass grafting, valve replacement, or combined procedures) are invited to provide specific additional informed consent for collection of epicardial adipose tissue fragments routinely excised during operative access and otherwise discarded as surgical waste. Operational launch is contingent on separate INCar tissue-specific approvals and will proceed via PRS record amendment when ready

A vizsgálat 3 csoportja

• Retrospective-Prospective

  Patients currently under the Principal Investigator's care who are already receiving tirzepatide for an independent clinical indication at the time of registry enrolment, with pre-tirzepatide articular, metabolic, and clinical documentation available in the medical record. Baseline pre-tirzepatide state is reconstructed retrospectively from structured medical record review under a specific informed consent attestation; Week-0 biospecimen and imaging acquisition is prospective. Expected n=10-20 from the Principal Investigator's existing patient pool. Recruitment Status: Not yet recruiting.

  Kezelés: Tirzepatide

• Fully Prospective

  Patients identified across the three clinical sites (IMSS Clínica Río Magdalena, INCMNSZ outpatient clinic, private practice in Mexico City) who are initiating tirzepatide under an independent clinical indication during the registry enrolment window, enrolled at or before Week 0 of tirzepatide exposure. Protocol is identical to Cohort 1 from Week 0 forward; the difference is the absence of pre-tirzepatide retrospective reconstruction. Expected n=10-20 recruited over 6-12 months. Recruitment Status: Not yet recruiting.

  Kezelés: Tirzepatide

• Surgical Tissue Subcohort

  Subset of enrolled Cohort 1 or Cohort 2 participants undergoing clinically indicated cardiac surgery at the Instituto Nacional de Cardiología Ignacio Chávez during follow-up (coronary artery bypass grafting, valve replacement, or combined procedures), providing additional informed consent for intraoperative collection of epicardial adipose tissue fragments routinely excised during cardiac access and discarded as surgical waste. Tissue acquisition does not modify the surgical procedure. This subcohort is declared at initial registration to establish scientific priority on direct human epicardial adipose tissue transcriptomic characterization under dual GIP/GLP-1 receptor agonism. Operational launch requires (a) favorable opinion of INCar Comité de Investigación and Comité de Ética en Investigación for the tissue-specific protocol, (b) formal agreement with INCar Servicio de Cirugía Cardiovascular, (c) PRS amendment reflecting operational launch. Recruitment Status: Not yet recruiting.

  Kezelés: Tirzepatide