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CARTIZ
Not yet recruitingCARTIZ Registry: Cartilage, Arthropathy and Imaging Under Tirzepatide in Zone-stratified Cohorts - A Four-Institute Mexican Observational Registry
Cartilage, Arthropathy and Imaging Under Tirzepatide in Zone-stratified Cohorts (CARTIZ): A Prospective Observational Multi-Institutional Registry of the VAT-Articular-Cardiac-Aging Axis in Adults Exposed to Tirzepatide in Mexico, With Quantitative Knee Cartilage T2 Mapping, Cardiac CT Epicardial Adipose Tissue Radiomic Phenotyping, HLA Stratification, Longitudinal Multi-Frequency Bioimpedance Body Composition, and a Prespecified Surgical Tissue Acquisition Subcohort
Lead sponsor
Assets
GLP-1 / incretin class catch-all / Tirzepatide
Listed sites
1
Recruiting sites
—
Enrollment
30
estimated
Study population
Osteoarthritis, Psoriasis / psoriatic arthritis
Key I/E criterion
—
Primary endpoints
•ACR20 response rate•Proportion of Week-4 ACR20 response mediated by biomarker panel in
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Study population text
Adults receiving tirzepatide under an independent clinical indication (type 2 diabetes, insulin resistance, obesity with or without associated metabolic disease, renal protection, metabolic hypertension, or off-label metabolic use) with current or historical documented musculoskeletal manifestation, enrolled across three clinical sites in Mexico City with identical protocol: IMSS Clínica Río Magdalena, INCMNSZ outpatient clinic, and a private practice site. The population is deliberately heterogeneous in tirzepatide indication and articular diagnosis to permit stratified analysis across the VAT-articular-cardiac-aging axis.
Inclusion criteria
3. Presence of at least one objectively documented musculoskeletal manifestation - current or historical - defined as any of: (i) inflammatory arthralgia affecting one or more joints with clinical, imaging, or serological support; (ii) CASPAR-positive psoriatic arthritis; (iii) radiographically documented knee osteoarthritis; (iv) enthesitis on physical examination or ultrasound; (v) documented inflammatory arthropathy of the spine or peripheral joints with a specialist diagnosis.
4. For the retrospective-prospective component: availability of clinical documentation of articular state prior to tirzepatide initiation in the patient's medical record. Documentation may include physical examination notes, imaging, laboratory values, or specialist consultation notes.
5. Signed informed consent for registry enrolment, longitudinal serum biobanking, HLA typing at INCMNSZ, quantitative knee MRI with T2 mapping at Ci3M UAM-Iztapalapa at Week 0 and Week 52, non-contrast cardiac CT at INCar at Week 0 and Week 52, multi-frequency bioelectrical impedance analysis at Universidad La Salle México at six timepoints, and (where applicable) medical record review. Each attestation is consented modularly within a single document.
6. Clinical plan to continue tirzepatide for at least 52 weeks from registry Week 0, based on the treating physician's evaluation of current clinical indication. Discontinuation during follow-up is captured as an outcome variable and does not remove the patient from the registry.
7. Capacity to attend scheduled follow-up visits and to undergo bilateral knee MRI at Ci3M (without severe claustrophobia requiring sedation, without absolute contraindication to MRI - see Exclusion 6) and non-contrast cardiac CT at INCar (without uncontrolled arrhythmia precluding ECG-gated imaging of diagnostic quality).
For the Surgical Tissue Subcohort (Cohort 3) only - additional criteria applied at the time of subcohort enrolment:
8s. Scheduled clinically indicated cardiac surgery at the Instituto Nacional de Cardiología Ignacio Chávez (coronary artery bypass grafting, valve replacement, or combined procedures) during registry follow-up.
9s. Specific additional informed consent for intraoperative collection of epicardial adipose tissue fragments.
Exclusion criteria
2. Major joint surgery within the 3 months prior to Week 0, or planned major joint surgery within the 12 months following Week 0, involving any joint scheduled for evaluation in the registry.
3. Intra-articular corticosteroid or hyaluronic acid injection within the 6 weeks prior to baseline biospecimen collection in any joint. Patients beyond the 6-week washout are eligible.
4. Active malignancy, with the exception of adequately treated non-melanoma skin carcinoma. History of malignancy in remission ≥5 years is permitted at the discretion of the treating investigator.
5. Current pregnancy, lactation, or planned pregnancy within the 12-month observation period.
6. Absolute contraindication to MRI, including non-MRI-compatible cardiac pacemaker or implanted defibrillator, ferromagnetic intracranial vascular clips, non-documented non-MRI-compatible cochlear implants, or other contraindication per the local MRI safety protocol.
7. Systemic rheumatologic disease other than psoriatic arthritis or osteoarthritis requiring active immunomodulation, specifically: seropositive rheumatoid arthritis on biologic therapy, active systemic lupus erythematosus on immunomodulation, active vasculitis on immunosuppression, or other systemic disease whose treatment confounds the inflammatory axis the registry is designed to characterize.
8. Inability to provide informed consent (cognitive impairment, language barrier not resolvable with site interpreter, or other incapacity to understand the protocol), or anticipated inability to complete the 52-week follow-up.
For the Surgical Tissue Subcohort (Cohort 3) only - additional exclusions:
9s. Prior major cardiac surgery resulting in extensive pericardial adhesions that preclude safe intraoperative EAT fragment collection, as assessed by the operating cardiac surgeon.
10s. Emergency cardiac surgery precluding the specific informed consent process.
Endpoints (14)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
4 endpointsChange in epicardial adipose tissue volume from Week 0 to Week 52
Time frame:week 0 and week 52
Visceral fat, change
change from baseline, improvement
Change in epicardial adipose tissue mean attenuation from Week 0 to Week 52
Time frame:week 0 and week 52
change from baseline, improvement
Change in epicardial adipose tissue radiomic texture composite z-score from Week 0 to Week 52
Time frame:week 0 and week 52
change from baseline, improvement
Longitudinal visceral adipose tissue trajectory over six timepoints
Time frame:week 0 through week 52
Visceral fat, change
change from baseline, improvement
Cardiometabolic biomarkers
1 endpointLongitudinal biomarker panel trajectories
Time frame:week 0 through week 52
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Other clinical outcomes
6 endpointsACR20 response rate at Week 4 in the Mechanistic Analysis Set
Time frame:week 4
threshold achievement, improvement
Proportion of Week-4 ACR20 response mediated by biomarker panel in the Mechanistic Analysis Set
Time frame:Week 4
descriptive
Change in knee cartilage T2 relaxation time from Week 0 to Week 52
Time frame:Week 0 and week 52
change from baseline, descriptive
Change in Leeds Enthesitis Index (LEI) from Week 0 to Week 52 in the psoriatic arthritis subgroup
Time frame:week 0 and week 52
change from baseline, improvement
Change in Madrid Sonographic Enthesitis Index (MASEI) from Week 0 to Week 52 in the psoriatic arthritis subgroup
Time frame:week 0 and week 52
change from baseline, improvement
Change in modified Nail Psoriasis Severity Index (mNAPSI) from Week 0 to Week 52 in the psoriatic arthritis subgroup
Time frame:Time Frame. Week 0 and Week 52.
change from baseline, improvement
Other (unclassified)
3 endpointsLongitudinal phase-angle trajectory (aging biomarker) over six timepoints
Time frame:week 0 through week 52
change from baseline, descriptive
HLA-stratified articular and cardiac response
Time frame:week 4 and week 52
descriptive
componentsacr20 response, epicardial adipose tissue radiomic change
Transcriptomic signature of epicardial adipose tissue in tirzepatide-exposed participants undergoing cardiac surgery
Time frame:At time of cardiac surgery, occurring within 36 months of enrolment
descriptive
Publications (7)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Arthritis & rheumatology (Hoboken, N.J.)2026 Mar 28PMID41903163doi:10.1002/art.70134via CT.gov reference
- Journal of the American College of Cardiology2025 Sep 9PMID40903131doi:10.1016/j.jacc.2025.06.058via CT.gov reference
- Journal of the American College of Cardiology2025 Feb 25PMID39566869doi:10.1016/j.jacc.2024.11.001via CT.gov reference
- Science translational medicine2017 Jul 12PMID28701474doi:10.1126/scitranslmed.aal2658via CT.gov reference
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.