LACROSS: Cardiovascular Registry of Atrial Fibrillation

Sponsor
Brazilian Clinical Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04456842
Collaborator
(none)
3,000
17
46.9
176.5
3.8

Study Details

Study Description

Brief Summary

Follow a representative sample of Latin American patients diagnosed with atrial fibrillation to set data on demographic characteristics, documenting antithrombotic therapy, describe the INR control level of VKA users, discontinuation rates and clinical outcomes, such as stroke, hemorrhage and death

Condition or Disease Intervention/Treatment Phase
  • Other: Patient Registry Data

Detailed Description

Patients will be followed 6 months and 1 year after the baseline visit and will be collected data of antithrombotic therapy, laboratory data, discontinuation rates of antithrombotic therapy and clinical outcomes.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Cardiovascular Registry of Atrial Fibrillation in Latin America: The LACROSS Study
Actual Study Start Date :
Aug 4, 2020
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Outcome Measures

Primary Outcome Measures

  1. INR control rate [12 months]

  2. Oral anticoagulation discontinuation rate [12 months]

  3. Percentage of death [12 months]

  4. Percentage of stroke [12 months]

  5. Percentage of systemic embolism [12 months]

  6. Percentage of myocardial infarction [12 months]

  7. Percentage of major bleeding [12 months]

  8. Percentage of electrical cardioversion [12 months]

  9. Percentage of percutaneous ablation of AF [12 months]

  10. Percentage of atrioventricular junction ablation [12 months]

  11. Percentage of patients that need of pacemaker implantation [12 monts]

  12. Percentage of other cardiovascular hospitalization [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age > 18 years-old that signed informed consent;

  • Atrial Fibrillation or Atrial Flutter at the time of inclusion documented in source document;

  • If the patient is not in atrial fibrillation or Atrial Flutter rhythm, s/he should have 2 electrographic records, at least 15 days apart between them, with one of them being performed within the last 6 months before enrollment (AF may be documented by 12-lead ECG, Holter monitor-24h);

Exclusion Criteria:
  • Patients who did not agree to participate.

  • Patients without possibility of monitoring for one year.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Interzonal General de Agudos "Dr. José Penna" Bahía Blanca Buenos Aires Argentina
2 DIM Clínica Privada Ramos Mejía Buenos Aires Argentina
3 Centro de Investigaciones Medicas Temperley (CIMeT) Temperley Buenos Aires Argentina
4 Hospital Italiano de La Plata Buenos Aires La Plata Argentina
5 Centro Modelo de Cardiologia San Miguel De Tucumán Tucumán Argentina
6 Centro Medico Luquez Córdoba Argentina
7 Prevención Cardiovascular Salta Salta Argentina
8 Servicios Médicos El Castaño San Juan Argentina
9 Instituto Cardiovascular San Luis San Luis Argentina
10 Centro de Investigaciones Clinicas del Litoral SRL Santa Fe Argentina
11 Hospital Provincial Dr. José Maria Cullen Santa Fe Argentina
12 Hospital Alvorada Taguatinga Ltda São Paulo Brazil
13 Sociedad de Cirugia de Bogota - Hospital de San Jose Bogotá Cundinamarca Colombia
14 Fundacion Valle del Lili Cali Valle Del Cauca Colombia
15 Francisco Gerardo Padilla Padilla Guadalajara Jalisco Mexico
16 Centro de Estudios Clínicos de Queretaro S.C. (CECLIQ) Querétaro City Querétaro Mexico
17 Centro para el Desarrollo de la Medicina y de Asistecia Medica Especializada S.C. Culiacán Sinaloa Mexico

Sponsors and Collaborators

  • Brazilian Clinical Research Institute

Investigators

  • Study Chair: Renato D. Lopes, MD, PhD, Instituto Brasileiro de Pesquisa Thomaz de Carvalho - BCRI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brazilian Clinical Research Institute
ClinicalTrials.gov Identifier:
NCT04456842
Other Study ID Numbers:
  • 001/2018
First Posted:
Jul 7, 2020
Last Update Posted:
Aug 24, 2022
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Brazilian Clinical Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2022