Coronary Artery Disease Clinical Trial
— CTO-HFOfficial title:
Percutaneous Coronary Intervention in Patients With Chronic Total Occlusion and Heart Failure.
The study investigates wheather CTO-PCI improves survival and heart failure related rehospitalization compared to optimal medical therapy (OMT). This hypothesis will be investigated within a large-scaled international, representative, prospective, randomized, controlled, open-label, event-driven, multicentre trial (trial acronym: CTO - Heart Failure) recruiting patients with planned CTO-PCI.
Status | Not yet recruiting |
Enrollment | 783 |
Est. completion date | December 2028 |
Est. primary completion date | March 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Written informed consent. - Presence of at least one CTO located at the proximal to midpart of left artery descending (LAD), or at proximal left circumflex (LCX), or at proximal to midpart LCX in left dominant system, or at proximal to distal right coronary artery (RCA). - LVEF <50% (assessed within 6 weeks prior to enrolment by transthoracic echocardiography (TTE) (Simpson biplane method) or cardiac magnetic resonance imaging (cMRI). - In patients with multivessel disease (MVD) and Syntax I score = 22, and all patients with type 2 diabetes and coronary 3 vessel disease, a heart team decision favouring CTO-PCI is needed. - Mandatory baseline imaging assessment (assessed within 6 weeks prior to enrolment): - TTE: Normal wall motion or hypokinesia in the CTO-territory. - In case of severe hypokinesia, akinesia or dyskinesia a viability testing with cMRI or myocardial scintigraphy (MS) indicating at least 50% of viability in the CTO territory (mandatory only in the presence of akinesia in the CTO-territory assessed by prior TTE) prior to PCI is mandatory. - Symptoms including dyspnea (according to the New York Heart Association (NYHA), classes II-III) or angina pectoris (according to Canadian Cardiovascular Society (CCS), classes II-IV). - In the absence of symptoms evidence of myocardial ischemia of at least 10% is needed being assessed by invasive or non-invasive imaging, such as stress-MRI, PET-CT-scan, myocardial scintigraphy, stress-echocardiography Exclusion Criteria: - Age <18 and >90 years. - Akinesia or dyskinesia assessed by TTE plus subendocardial late gadolinium enhancement of >50% assessed by cMRI or MS in the CTO-territory or any evidence of transmural scarring of the CTO-territory (i.e. 100%). - Presence of terminal kidney disease with need for renal replacement therapy. - Severe chronic kidney disease (defined as GFR < 25 ml/min). - Type I myocardial infarction (ST segment elevation or non-ST segment elevation myocardial infarction (STEMI or NSTEMI)) related to critical arteriosclerosis < 30 days. - End-stage heart failure (defined by constant administration of intravenous inotropes, use of prolonged assist devices (more than 5 days), listing for high urgent cardiac transplantation). - Cardiogenic shock (< 30 days). - Heart team decision favoring CABG surgery (in the presence of coronary multivessel disease with intermediate to high SYNTAX I score). - Grade II-III heart valve disorders requiring interventional or surgical treatment within 3 months. - Right-sided heart failure with echocardiographic evidence of severe right ventricular dysfunction. - COPD requiring long-term oxygen therapy. - Non-cardiac comorbidity with life expectancy < 12 months. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Universitätsmedizin Mannheim | Herzzentrum Lahr, IHF GmbH - Institut für Herzinfarktforschung |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite of all-cause mortality or heart failure related rehospitalization. | Heart failure related rehospitalization is defined as a rehospitalization due to worsening heart failure requiring intravenous therapy as the primary cause, or as a result of another cause but associated with worsening heart failure at the time of admission, or as a result of another cause but complicated by worsening heart failure during its course | up to 3 years | |
Secondary | Canadian cardiovascular society (CCS) class | angina pectoris | up to 3 years | |
Secondary | All-cause mortality. | up to 3 years | ||
Secondary | Heart failure related rehospitalization. | up to 3 years | ||
Secondary | MACCE | MACCE are defined as the composite of all-cause death, myocardial infarction (type I and II), any further type of coronary revascularization (i.e. PCI or CABG) based on functional invasive assessment by fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR), and stroke. | up to 3 years | |
Secondary | Number of participanty with rehospitalization due to cardiac diseases beyond heart failure. | up to 3 years | ||
Secondary | assessment of quality of life | Seattle angina questionnaire (SAQ) (0-100; 75-100 normal). | up to 3 years | |
Secondary | cost effectivenes | direct and indirect health care related costs | up to 3 years | |
Secondary | Re-assessment of LVEF | up to 3 years | ||
Secondary | New York Heart association (NYHA) class | dyspnea | up to 36 months |
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