International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Heart Failure Trial

Phase 3

Not yet recruiting

• Conditions: Coronary Artery Disease; Cognitive Impairment; Heart Failure

• Registration Number: NCT06566183
• Lead Sponsor: NYU Langone Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-20
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Inclusion Criteria:<br><br> - Left ventricular ejection fraction (LVEF) = 40% within prior 6 months (any local<br> measurement, made within the past 6 months using echocardiography, multigated<br> acquisition (MUGA), computed tomography (CT) scanning, magnetic resonance imaging<br> (MRI), or ventricular angiography is acceptable, provided no subsequent measurement<br> above 40%)<br><br> - Participants with multivessel CAD (defined as severe 3 vessel disease or 2 vessel<br> disease including left anterior descending (LAD) artery disease) on coronary CT<br> angiography (CCTA) or invasive coronary angiography<br><br> - CAD amenable to either PCI or CABG as determined by the local heart team<br><br> - Participant is willing to comply with all aspects of the protocol, including<br> adherence to the assigned strategy, medical therapy and follow-up visits<br><br> - Participant is able and willing to give written informed consent<br><br>Exclusion Criteria:<br><br> - Decompensated heart failure or cardiogenic shock in the past 48 hours prior to<br> randomization<br><br> - Concomitant significant valvular heart disease requiring surgery<br><br> - Prior cardiac surgery<br><br> - Dementia with loss of capacity to consent (clinically evident or previously<br> diagnosed)<br><br> - Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any<br> time<br><br> - History of noncompliance with medical therapy<br><br> - Life expectancy less than the duration of the trial due to non-cardiovascular<br> comorbidity<br><br> - Pregnancy (known to be pregnant; to be confirmed before randomization, if<br> applicable)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite Cognitive Score;Kansas City Cardiomyopathy Questionnaire (KCCQ) Score;Composite Number of: Death, Nonfatal Myocardial infarction (MI), Stroke, and Hospitalization for HF

Secondary Outcome Measures

Name	Time	Method
Composite Number of: Mild Cognitive Impairment (MCI), Probable Dementia or Persistent Disability;Composite Number of: Death or Hospitalization for HF;Composite Number of: Death or Hospitalization for Cardiovascular (CV) Cause;Seattle Angina Questionnaire (SAQ) Physical Limitations and Quality of Life Domain Score;Self-Care of Heart Failure Index (SCHFI)