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Observational Registry on Clinical Outcome After Diagnosis of Chronic Total Occlusions (PETS-CTO)

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ClinicalTrials.gov Identifier: NCT04145167
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : July 15, 2021
Sponsor:
Information provided by (Responsible Party):
Pierfrancesco Agostoni, Ziekenhuis Netwerk Antwerpen (ZNA)

Brief Summary:

This registry aims at enrolling all consecutive patients presenting with at least one chronic total occlusion at coronary angiogram as diagnosed during angiography in our catheterization laboratory during 1 year.

All patients will undergo - whenever possible - a cardiopulmonary excercise test and a non-invasive investigation for myocardial ischemia/viability (by means of echo-dobutamine stress test or perfusion scintigraphy or cardiac magnetic resonance) prior to any eventual revascularization therapy. All patients - including those treated by medical therapy only - will repeat the same investigations after one year of follow-up. In addition to these investigations, clinical outcome and quality of life (including the Seattle Angina Questionnarie and a dedicated depression questionnaire) will be evaluated at baseline and at follow-up.

Primary objective of this study is to investigate the improvement in physical conditions (as expressed by the performance at follow-up CP test), the reduction in ischemia (as evaluated by follow-up non-invasive imaging tests) and the severity of angina according to clinical assessment (including Seattle Angina Questionnaires [SAQ], Canadian Class Score[CCS] and 6-mins walking test).


Condition or disease
Chronic Total Occlusion of Coronary Artery Angina Pectoris

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Prospective Evaluation of Treatment Strategies in Patients Presenting With Chronic Total Occlusions at Coronary Angiogram
Actual Study Start Date : October 10, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Group/Cohort
Medical Treatment
This group will include all patients with a diagnose of coronary chronic total occlusions who will be treated by medical therapy only, for any clinical/angiographic/instrumental indication.
Percutaneous intervention
This group will include all patients with a diagnose of coronary chronic total occlusions who will be treated by percutaneous intervention (CTO-PCI), as indicated by the heart-team.
Surgical treatment
This group will include all patients with a diagnose of coronary chronic total occlusions (generally not isolated) who will be treated by means of coronary artery by-pass grafting (CABG), as indicated by heart-team decision.



Primary Outcome Measures :
  1. Reduction in ischemia and angina paramteres [ Time Frame: 1 year ]
    Parameters of Cardiopulmonary Exercise test, non-invasive imaging tests and angina questionnaires.


Secondary Outcome Measures :
  1. Composite of major adverse clinical events [ Time Frame: 1 year ]
    Composite of cardiac death, myocardial infarction and ischemia-driven revascularization.

  2. Re-hospitalization [ Time Frame: 1 year ]
    Episodes of re-hospitalization due to angina/heart-failure

  3. Outpatient clinic evaluation [ Time Frame: 1 year ]
    Need for specialist/non-specialist outpatient evaluation because angina



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population includes all patients aged >18 with coronary artery disease undergoing coronary catheterization. Key condition to be enrolled in the registry is the evidence of chronic total occlusion and the will to participate in the study.
Criteria

Inclusion Criteria:

  • Presence of at least one untreated CTO at basal angiography (defined as a total occlusion in any major coronary vessel or relevant side branches [reference vessel diameter ≥2.5mm or as judged by two independent interventional cardiologists], with TIMI 0 in the distal segment and at least 3 months old - according to clinical information or of unknown age).
  • In patients with history of CABG, a CTO can be included when the occlusion is located in a vessel without a graft in the distal vessel or in case of graft occlusion.
  • Age > 18 years
  • Willing to participate and able to understand, read and sign the informed consent document after the diagnostic procedure

Exclusion Criteria:

  • Lack of will to participate in the study or inability to provide informed consent (e.g. by patient admitted with cardiac arrest or unconscious)

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): NCT04145167


Contacts
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Contact: Pierfrancesco Agostoni, MD PhD 0032495637041 agostonipf@gmail.com

Locations
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Belgium
ZNA Middelheim Recruiting
Antwerp, Belgium, 2020
Contact: Pierfrancesco Agostoni, MD PhD    0032495637041 ext 0032495637041    agostonipf@gmail.com   
Principal Investigator: Pierfrancesco Agostoni, MD PhD         
Principal Investigator: Carlo Zivelonghi, MD         
Sponsors and Collaborators
Ziekenhuis Netwerk Antwerpen (ZNA)
Publications:

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Responsible Party: Pierfrancesco Agostoni, Dr, Ziekenhuis Netwerk Antwerpen (ZNA)
ClinicalTrials.gov Identifier: NCT04145167    
Other Study ID Numbers: EC 5269
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Pierfrancesco Agostoni, Ziekenhuis Netwerk Antwerpen (ZNA):
chronic total occlusion
coronary percutaneous intervention
ischemic heart disease
Additional relevant MeSH terms:
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Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations