Observational Registry on Clinical Outcome After Diagnosis of Chronic Total Occlusions

NCT04145167 | Unknown

• 1 other identifier: EC 5269
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Total Occlusion of Coronary Artery; Angina Pectoris

Keywords

chronic total occlusion; coronary percutaneous intervention; ischemic heart disease

Outcome Measures

Primary Outcomes (1)

• Reduction in ischemia and angina paramteres

  Parameters of Cardiopulmonary Exercise test, non-invasive imaging tests and angina questionnaires.

  1 year

Secondary Outcomes (3)

• Composite of major adverse clinical events

  1 year

• Re-hospitalization

  1 year

• Outpatient clinic evaluation

  1 year

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ziekenhuis Netwerk Antwerpen (ZNA): lead

Study Sites (1)

ZNA Middelheim

Antwerp, 2020, Belgium

RECRUITING

Related Publications (8)

• Tajti P, Brilakis ES. Chronic Total Occlusion Percutaneous Coronary Intervention: Evidence and Controversies. J Am Heart Assoc. 2018 Jan 12;7(2):e006732. doi: 10.1161/JAHA.117.006732. No abstract available.

  PMID: 29330258 BACKGROUND

• Werner GS, Martin-Yuste V, Hildick-Smith D, Boudou N, Sianos G, Gelev V, Rumoroso JR, Erglis A, Christiansen EH, Escaned J, di Mario C, Hovasse T, Teruel L, Bufe A, Lauer B, Bogaerts K, Goicolea J, Spratt JC, Gershlick AH, Galassi AR, Louvard Y; EUROCTO trial investigators. A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions. Eur Heart J. 2018 Jul 7;39(26):2484-2493. doi: 10.1093/eurheartj/ehy220.

  PMID: 29722796 BACKGROUND

• Tomasello SD, Boukhris M, Giubilato S, Marza F, Garbo R, Contegiacomo G, Marzocchi A, Niccoli G, Gagnor A, Varbella F, Desideri A, Rubartelli P, Cioppa A, Baralis G, Galassi AR. Management strategies in patients affected by chronic total occlusions: results from the Italian Registry of Chronic Total Occlusions. Eur Heart J. 2015 Dec 1;36(45):3189-98. doi: 10.1093/eurheartj/ehv450. Epub 2015 Sep 2.

  PMID: 26333367 BACKGROUND

• Jang WJ, Yang JH, Choi SH, Song YB, Hahn JY, Choi JH, Kim WS, Lee YT, Gwon HC. Long-term survival benefit of revascularization compared with medical therapy in patients with coronary chronic total occlusion and well-developed collateral circulation. JACC Cardiovasc Interv. 2015 Feb;8(2):271-279. doi: 10.1016/j.jcin.2014.10.010.

  PMID: 25700750 BACKGROUND

• Abdullah SM, Hastings JL, Amsavelu S, Garcia-Morales F, Hendrix F, Karatasakis A, Danek BA, Karacsonyi J, Rangan BV, Roesle M, Khalili H, Banerjee S, Brilakis ES. Percutaneous Coronary Intervention of Coronary Chronic Total Occlusions Improves Peak Oxygen Uptake During Cardiopulmonary Exercise Testing. J Invasive Cardiol. 2017 Mar;29(3):83-91.

  PMID: 28255103 BACKGROUND

• Yeh RW, Tamez H, Secemsky EA, Grantham JA, Sapontis J, Spertus JA, Cohen DJ, Nicholson WJ, Gosch K, Jones PG, Valsdottir LR, Bruckel J, Lombardi WL, Jaffer FA. Depression and Angina Among Patients Undergoing Chronic Total Occlusion Percutaneous Coronary Intervention: The OPEN-CTO Registry. JACC Cardiovasc Interv. 2019 Apr 8;12(7):651-658. doi: 10.1016/j.jcin.2018.12.029. Epub 2019 Mar 13.

  PMID: 30878475 BACKGROUND

• Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

  PMID: 21670242 BACKGROUND

• Poletti E, Zivelonghi C, Castaldi G, Vermeersch P, Convens C, Selleslagh P, Prihadi E, Droogmans S, Scott B, Agostoni P. Prospective Evaluation of Treatment Strategies in Patients Presenting With Chronic Total Occlusion: The PETS-CTO Registry. Catheter Cardiovasc Interv. 2025 Jul;106(1):443-453. doi: 10.1002/ccd.31559. Epub 2025 Apr 28.

  PMID: 40296468 DERIVED

MeSH Terms

Conditions

Angina Pectoris; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pierfrancesco Agostoni, MD PhD

CONTACT

0032495637041; agostonipf@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: October 10, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: July 15, 2021

Record last verified: 2021-07

Locations

BE (1)