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Cardiovascular Innovation & Research Institute 's NEXUS Registry, the Whole is Greater Than the Parts.

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ClinicalTrials.gov Identifier: NCT03428048
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Collaborator:
Valley View Hospital
Information provided by (Responsible Party):
Cardiovascular Innovation and Research Institute

Brief Summary:
Information gathered from the patients via a disease specific questionnaire will be married to data from the National Cardiovascular Data Registry (NCDR®). Details will be continuously analyzed and used to direct quality of care at our center. Our institution is categorized as a low-volume institution for percutaneous coronary intervention (PCI) for coronary artery disease treatment as well as surgical and endocardial ablation for the management of atrial fibrillation (Afib). The association between operator volume and quality has primarily focused on rare complications, such as mortality. Our aim is to highlight the advantages of receiving care close to home. A benefit of offering the procedures to treat diseases at centers that have lower volumes is to improve patients' outcomes while also providing more convenient access to quality care. The key outcome from the patients' experience is alleviation of their symptoms while increasing function and quality of life. To date, there have been no studies documenting the health status benefits of PCI and surgical / endocardial ablation for coronary artery disease and Afib, respectively with low- volume operators. In this study, we sought to examine the feasibility of implementing patient-reported outcomes into clinical care and to demonstrate evidence of benefits, from patients' perspectives, of receiving treatment by low-volume operators.

Condition or disease
Coronary Artery Disease Atrial Fibrillation

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: NEXUS Registry: An Outcomes Database Which Tracks Patient -Reported Outcomes After Percutaneous Coronary Intervention for Coronary Artery Disease Along With Surgical and Subcutaneous Ablation for the Management of Atrial Fibrillation.
Actual Study Start Date : March 2016
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The primary outcome is the 6-month change in SAQ mean score (6-month mean - baseline mean). [ Time Frame: Initial Analysis at baseline (administered pre-PCI procedure or during in-patient status), follow-up intervals are 6 months after then annually thereafter for up to 10 years. ]
    For adults with coronary artery disease who experience PCI the key outcome, from patients' perspectives, is the alleviation of their symptoms, function, and quality of life, which provides rationale for using the 6-month change in SAQ as the primary outcome.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All comers outcomes registry
Criteria

Inclusion Criteria:

Candidates will be included in the study only if all the following conditions are met:

  1. Age >18 years
  2. The subject has been informed of the nature of the study, agrees to its provisions, is able to comprehend, and has provided informed consent.
  3. The subject is available for follow-up.
  4. The subject has a diagnosis of coronary artery disease or Afib.

Exclusion Criteria:

Candidates will be excluded from the study if any of the following conditions are present:

  1. Failure and / or inability and / or unwillingness to provide informed consent.
  2. Likely problems, in the judgement of the investigators, with maintaining follow-up.

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): NCT03428048


Contacts
Contact: Kim M Williams, MPH 970-384-7433 kim.williams@vvh.org

Locations
United States, Colorado
Valley View Hospital Recruiting
Glenwood Springs, Colorado, United States, 81601
Contact: Kim M Williams, MPH    970-384-7433    kim.williams@vvh.org   
Contact: Sean O'Flinn    970-384-7436    sean.o'flinn@vvh.org   
Principal Investigator: Frank A Laws, MD         
Sponsors and Collaborators
Cardiovascular Innovation and Research Institute
Valley View Hospital
Investigators
Principal Investigator: Frank A Laws, MD Valley View Hospital

Responsible Party: Cardiovascular Innovation and Research Institute
ClinicalTrials.gov Identifier: NCT03428048     History of Changes
Other Study ID Numbers: 2015_01
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Atrial Fibrillation
Myocardial Ischemia
Pathologic Processes
Arteriosclerosis