Trial record 17 of 215 for:    heart surgery OR coronary artery bypass surgery OR heart transplant | Open Studies | NIH, U.S. Fed

ISCHEMIA-Chronic Kidney Disease Trial (ISCHEMIA-CKD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by New York University School of Medicine
Sponsor:
Collaborators:
New York University
Vanderbilt University
Albany Stratton VA Medical Center
East Carolina University
Duke University
Stanford University
Harvard University
Columbia University
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01985360
First received: November 4, 2013
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

The purpose of the ISCHEMIA-CKD trial is to determine the best management strategy for patients with stable ischemic heart disease (SIHD), at least moderate ischemia and advanced chronic kidney disease (CKD; estimated glomerular filtration rate [eGFR] <30 or on dialysis). This is a multicenter randomized controlled trial with a target randomization of ~1000 patients with advanced CKD and at least moderate ischemia on stress testing. Participants will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those who fail OMT. The trial is designed to run seamlessly in parallel to the main ISCHEMIA trial as a companion ancillary trial.

SPECIFIC AIMS

A. Primary Aim. The primary aim of the ISCHEMIA-CKD trial is to determine whether an invasive strategy of routine early catheterization followed by optimal revascularization, in addition to OMT, will reduce the primary composite endpoint of death or nonfatal myocardial infarction in SIHD patients with advanced CKD and at least moderate ischemia over an average follow-up of approximately 4 years compared with an initial conservative strategy of OMT alone with catheterization reserved for those who fail OMT. The primary endpoint is time to centrally adjudicated death or nonfatal myocardial infarction (MI).

B. Secondary Aims. Major: To compare angina-related quality of life between the INV and CON strategies. Other secondary aims include: comparing the incidence of the composite of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure; composite of cardiovascular death or nonfatal myocardial infarction; cardiovascular death; non-fatal myocardial infarction; all-cause death; stroke; hospitalization for heart failure or unstable angina

Condition: Coronary Disease Procedure: Cardiac catheterization Phase: Phase III Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions Phase: Phase III Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III


Condition Intervention
Cardiovascular Diseases
Coronary Artery Disease
Heart Diseases
Myocardial Ischemia
Kidney Disease
End Stage Renal Failure on Dialysis
Procedure: Cardiac Catheterization
Procedure: Coronary Artery Bypass Graft Surgery
Procedure: Percutaneous Coronary Intervention
Behavioral: Lifestyle
Drug: Medication

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: International Study of Comparative Health Effectiveness With Medical and Invasive Approaches—Chronic Kidney Disease Trial

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Time to first occurrence of death or nonfatal myocardial infarction. [ Time Frame: ~four year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Angina control per Seattle Angina Questionnaire (SAQ) Angina Frequency Scale [ Time Frame: ~four year follow-up ] [ Designated as safety issue: No ]
  • Composite of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure [ Time Frame: ~four year follow-up ] [ Designated as safety issue: No ]
  • Death [ Time Frame: ~four year follow-up ] [ Designated as safety issue: No ]
  • Cardiovascular death [ Time Frame: ~four year follow-up ] [ Designated as safety issue: No ]
  • Myocardial Infarction [ Time Frame: ~four year follow-up ] [ Designated as safety issue: No ]
  • Resuscitated cardiac arrest [ Time Frame: ~four year follow-up ] [ Designated as safety issue: No ]
  • Hospitalization for unstable angina [ Time Frame: ~four year follow-up ] [ Designated as safety issue: No ]
  • Hospitalization for heart failure [ Time Frame: ~four year follow-up ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: ~four year follow-up ] [ Designated as safety issue: No ]
  • Cardiovascular death or non-fatal myocardial infarction [ Time Frame: ~four year follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: January 2014
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Invasive Strategy (INV)
Routine invasive strategy with cardiac catheterization followed by revascularization (Percutaneous Coronary Intervention or Coronary Artery Bypass Graft Surgery) plus optimal medical therapy.
Procedure: Cardiac Catheterization
Narrowed blood vessels can be opened without surgery using stents or can be bypassed with surgery. To determine which is the best approach for you the doctor needs to look at your blood vessels to see where the narrowings are and how much narrowing there is. This is done by a procedure known as a cardiac catheterization.
Other Name: cath
Procedure: Coronary Artery Bypass Graft Surgery
Artery narrowing is bypassed during surgery with a healthy artery or vein from another part of the body. This is known as coronary artery bypass grafting, or CABG (said "cabbage"). The surgery creates new routes around narrowed and blocked heart arteries. This allows more blood flow to the heart.
Other Name: CABG
Procedure: Percutaneous Coronary Intervention
Percutaneous coronary intervention may be done as part of the cardiac catheterization procedure. With this procedure a small, hollow, mesh tube (stent) is inserted into the narrowed part of the artery. The stent pushes the plaque against the artery wall, and opens the vessel to allow better blood flow.
Other Name: PCI
Behavioral: Lifestyle
Diet, physical activity, smoking cessation
Other Name: Behavior change
Drug: Medication
antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
Other Name: Pharmacologic Therapy
Active Comparator: Conservative Strategy (CON)
Optimal medical therapy with cardiac catheterization and revascularization reserved for patients with OMT failure.
Behavioral: Lifestyle
Diet, physical activity, smoking cessation
Other Name: Behavior change
Drug: Medication
antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
Other Name: Pharmacologic Therapy

Detailed Description:

BACKGROUND:

Among patients with advanced CKD, cardiovascular disease is the leading cause of death,15-30 times higher than the age-adjusted cardiovascular mortality rate in the general population. The projected 4-year mortality is >50% in patients with advanced CKD and is worse than that for patients in the general population who have cancers, heart failure, stroke or MI. Participants with advanced CKD are 5-10 times more likely to die than to reach end stage renal disease (ESRD). Despite this, ~80% of contemporary coronary artery disease (CAD) trials exclude participants with advanced CKD. Most of the treatments aimed at reducing cardiovascular events in advanced CKD are therefore extrapolated from cohorts without advanced CKD. Participants with advanced CKD and cardiovascular disease are undertreated with less frequent use of statins and revascularization therapies, and the optimal management approach to these patients is unknown. Participants with advanced CKD are notably underrepresented in contemporary trials comparing revascularization with medical therapy in SIHD patients, such as the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial or the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial,making any assessment about the efficacy of revascularization plus medical therapy vs. initial medical therapy alone in this cohort problematic.

Participants with advanced CKD are at increased risk for complications of the assigned invasive procedure, specifically contrast-induced acute kidney injury (AKI), dialysis, major bleeding and short-term risk of death. However, there is controversy in the medical literature regarding the incidence (<1% to >30%), effective treatment (saline hydration, N-acetyl cysteine, or sodium bicarbonate) and prognosis of contrast induced AKI (<0.5% to >5% requiring dialysis). In addition although contrast induced AKI have been associated with increase in short-term mortality residual confounding in these studies makes interpretation difficulty. Moreover it is unknown if these short-term increased risks are offset by long-term benefits. Limited observational study in the CKD cohort suggests a survival benefit of revascularization when compared with medical therapy alone long-term, despite increase in short-term risks. However, the medical therapy in these trials was not optimized, drug eluting stents were rarely used and there is undoubtedly inherent selection and ascertainment bias with observational studies. The above has resulted in substantial clinical equipoise in the management of these patients with the rates of revascularization of only around 10-45%. The results of ISCHEMIA-CKD will have profound implications for guidelines, health policy, and clinical practice.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least moderate ischemia on a stress imaging test with nuclear myocardial perfusion (≥10% myocardium), echo or cardiac magnetic resonance wall motion (≥3/16 segments with stress-induced severe hypokinesis or akinesis).
  • Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits
  • Participant is willing to give written informed consent
  • Age ≥ 21 years
  • Advanced CKD (eGFR <30 or on dialysis)

Exclusion Criteria:

  • Left Ventricular Ejection Fraction < 35%
  • History of unprotected left main stenosis >=50% on prior coronary computed tomography angiography (CCTA) or prior cardiac catheterization (if available).
  • Finding of "no obstructive CAD" (<50% stenosis in all major epicardial vessels) on prior CCTA or prior catheterization, performed within 12 months
  • Coronary anatomy unsuitable for either percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG)
  • Unacceptable level of angina despite maximal medical therapy
  • Very dissatisfied with medical management of angina
  • History of noncompliance with medical therapy
  • Acute coronary syndrome within the previous 2 months
  • PCI within the previous 12 months
  • Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time
  • History of ventricular tachycardia requiring therapy for termination, or symptomatic sustained ventricular tachycardia not due to a transient reversible cause
  • New York Heart Association class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months
  • Non-ischemic dilated or hypertrophic cardiomyopathy
  • Severe valvular disease or valvular disease likely to require surgery during the trial
  • Allergy to radiographic contrast that cannot be adequately pre-medicated, or any prior anaphylaxis to radiographic contrast
  • Planned major surgery necessitating interruption of dual antiplatelet therapy (note that patients may be eligible after planned surgery)
  • Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity
  • Pregnancy (known to be pregnant; to be confirmed before randomization, if applicable)
  • Patient who, in the judgment of the patient's physician, is likely to have significant unprotected left main stenosis
  • Enrolled in a competing trial that involves a non-approved cardiac drug or device
  • Inability to comply with the protocol
  • Exceeds the weight or size limit for cardiac catheterization at the site
  • Canadian Cardiovascular Society Class IV angina, including unprovoked rest angina
  • High risk of bleeding which would contraindicate the use of dual antiplatelet therapy
  • Cardiac transplant recipient
  • Prior CABG at any time, unless coronary anatomy has been demonstrated within the previous 12 months to be suitable for PCI or CABG to accomplish complete revascularization of ischemic areas.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01985360

Contacts
Contact: Sripal Bangalore, MD, MHA 212-263-4225 ISCHEMIA@nyumc.org
Contact: Stephanie Mavromichalis 212-263-4225 ISCHEMIA@nyumc.org

Locations
United States, New York
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Sripal Bangalore         
Sponsors and Collaborators
New York University School of Medicine
New York University
Vanderbilt University
Albany Stratton VA Medical Center
East Carolina University
Duke University
Stanford University
Harvard University
Columbia University
Investigators
Principal Investigator: Sripal Bangalore, MD, MHA New York University School of Medicine
Study Chair: Judith Hochman, MD ISCHEMIA trial Chair, New York University School of Medicine
Study Chair: David Maron, MD ISCHEMIA trial Co-chair, Vanderbilt University
  More Information

Additional Information:
No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01985360     History of Changes
Other Study ID Numbers: 1 - Bangalore, U01HL117905
Study First Received: November 4, 2013
Last Updated: May 8, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Myocardial Ischemia
Ischemia
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Arteriosclerosis
Vascular Diseases
Pathologic Processes
Urologic Diseases

ClinicalTrials.gov processed this record on July 31, 2014