Registry for patients with amyloidosis
Institutional Registry of Amyloidosis (Hospital Italiano de Buenos Aires)
Hospital Italiano de Buenos Aires · NCT01347047
This study is creating a registry to collect important information about patients with amyloidosis to better understand the disease and improve care for those affected.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Italiano de Buenos Aires (other) |
| Locations | 1 site (Buenos Aires, Buenos Aires) |
| Trial ID | NCT01347047 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a population-based registry for amyloidosis at the Hospital Italiano de Buenos Aires. It will systematically collect data on risk factors, diagnosis, prognosis, treatment, and monitoring of patients with amyloidosis. The registry will help describe the occurrence and clinical characteristics of amyloidosis in the population, enhancing understanding of the disease and improving patient care. By analyzing data from electronic health records, the study seeks to confirm cases of amyloidosis and gather comprehensive epidemiological information.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with confirmed or clinically compatible cases of amyloidosis.
Not a fit: Patients who refuse to participate or do not provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could lead to improved diagnosis, treatment, and monitoring of amyloidosis, ultimately enhancing patient outcomes.
How similar studies have performed: While registries for amyloidosis are not widely established, similar epidemiological approaches have shown success in other conditions, suggesting potential for valuable insights in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Cases of amyloidosis are captured by electronic medical records whenever the physician register amyloidosis as a patient diagnosis, and/or there is amyloidosis in a biopsy specimen and/or requests for the following studies of an adult patient: plasma kappa and lambda light-chain concentrations, the kappa: lambda ratio, transthoracic Doppler echocardiography, or cardiovascular magnetic resonance examination or pyrophosphate scintigraphy From the possible cases included in the IRA, a prospective review of the electronics health records was performed to confirm the presence of amyloidosis \*\*Inclusion Criteria: 1 AND (2 or 3) 1. Patients over 18 years: 2. Confirmed amyloidosis: Proof of deposit of amyloid pathology by tissue biopsy in abdominal fat, bone marrow, rectum or organ involved (eg, kidney, liver, sural nerve) 3. Clinically compatible case of Amyloidosis : * Exclusion Criteria: Refusal to participate in the study or the informed consent process by the patient or legal representative or refusal to consent to participate in the study in the case of minors.
Where this trial is running
Buenos Aires, Buenos Aires
- Hospital Italiano de Buenos Aires — Buenos Aires, Buenos Aires, Argentina (RECRUITING)
Study contacts
- Principal investigator: María Lourdes Posadas-Martínez, MD — Hospital Italiano de Buenos Aires, Argentina
- Study coordinator: María L Posadas-Martínez, MD, PhD
- Email: maria.posadas@hospitalitaliano.org.ar
- Phone: +54 11 4959 0200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Amyloidosis, Known or Suspected, rare diseases