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Cardiovascular Registry of Atrial Fibrillation (LACROSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04456842
Recruitment Status : Not yet recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Brazilian Clinical Research Institute

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
Atrial Fibrillation Atrial Flutter 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Cardiovascular Registry of Atrial Fibrillation in Latin America: The LACROSS Study
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Patient Registry Data
    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.


Primary Outcome Measures :
  1. INR control rate [ Time Frame: 12 months ]
  2. Oral anticoagulation discontinuation rate [ Time Frame: 12 months ]
  3. Percentage of death [ Time Frame: 12 months ]
  4. Percentage of stroke [ Time Frame: 12 months ]
  5. Percentage of systemic embolism [ Time Frame: 12 months ]
  6. Percentage of myocardial infarction [ Time Frame: 12 months ]
  7. Percentage of major bleeding [ Time Frame: 12 months ]
  8. Percentage of electrical cardioversion [ Time Frame: 12 months ]
  9. Percentage of percutaneous ablation of AF [ Time Frame: 12 months ]
  10. Percentage of atrioventricular junction ablation [ Time Frame: 12 months ]
  11. Percentage of patients that need of pacemaker implantation [ Time Frame: 12 monts ]
  12. Percentage of other cardiovascular hospitalization [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient with Atrial Fibrilation or Atrial Flutter
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456842


Contacts
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Contact: Renato D. Lopes, MD, PhD 55 11 5904 7339 renato.lopes@duke.edu

Locations
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Brazil
Hospital Alvorada Taguatinga Ltda
São Paulo, Brazil
Contact: Pedro Gabriel Melo de Barros e Silva, MD, PhD       drpedrobarros80@gmail.com   
Sponsors and Collaborators
Brazilian Clinical Research Institute
Investigators
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Study Chair: Renato D. Lopes, MD, PhD Instituto Brasileiro de Pesquisa Thomaz de Carvalho - BCRI
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Responsible Party: Brazilian Clinical Research Institute
ClinicalTrials.gov Identifier: NCT04456842    
Other Study ID Numbers: 001/2018
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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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:
Atrial Fibrilation
Antithrombotic therapy
Atrial Flutter
Additional relevant MeSH terms:
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Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes