Prospective Evaluation of Treatment Strategies in Patients Presenting With Chronic Total Occlusions at Coronary Angiogram
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Reduction in ischemia and angina paramteres
研究概览
简要总结
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).
详细描述
Background The clinical benefits of performing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) represent still a matter of debate in the community of interventional cardiologists[1]. Improvements in terms of symptoms' relief after successful CTO recanalization are growing, with emerging data from randomized clinical trials (RCT) [2] in addition to the already existing large registries[3,4]. In addition, these registries offer data supporting reduction in hard clinical endpoints - including incidence of myocardial infarction (MI) and cardiac death - which however, has so far not been confirmed in RCT. Furthermore, data regarding reduction in ischemia burden after successful CTO-PCI - despite intuitive - and its clinical implications are still lacking, with only a small registry[5] reporting on improved Cardiopulmonary Exercise parameters after successful CTO recanalization. It's also widely known that chronic (refractory) angina significantly impacts the daily life of patients with CTO lesions, not only affecting their quality of life, but also leading to a de-conditioning and a self-limitation in daily activities, creating a negative loop that further reduce the efforts tolerance in these delicate patients. Moreover, recent data suggest that incidence of depression is common among patients with known coronary CTO, and that benefits from successful CTO-PCI may include improvements in psychological health[6].
Of note, the outcome of patients presenting with CTO lesions has been so far investigated only in selected groups of populations (including those with evidence of ischemia/viability, those undergoing CTO-PCI procedures...). However, a systematic and prospective analysis of all consecutive patients presenting with CTO lesions during coronary angiogram, independently by any therapeutic strategy, is so far lacking.
Objective Aim of this registry is to include all consecutive patients presenting with CTO lesion in a relevant coronary vessel (or relevant side branch [namely any coronary vessel with diameter ≥2.5mm]) during cardiac catheterization, to comprehensively analyse their characteristics and to investigate the clinical outcome at 1 year, independently of their therapeutic work-up.
Methodology All patients undergoing coronary angiogram in our centre will be screened for eligibility in the registry. Inclusion and exclusion criteria are here reported.
Inclusion Criteria:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Lack of will to participate in the study or inability to provide informed consent (e.g. by patient admitted with cardiac arrest or unconscious)
结局指标
主要结局
Reduction in ischemia and angina paramteres
时间窗: 1 year
Parameters of Cardiopulmonary Exercise test, non-invasive imaging tests and angina questionnaires.
次要结局
- Composite of major adverse clinical events(1 year)
- Outpatient clinic evaluation(1 year)
- Re-hospitalization(1 year)
研究者
Pierfrancesco Agostoni
Dr
Ziekenhuis Netwerk Antwerpen (ZNA)