Trials in Planning Phase

Proposed/Pending Funding

ISCHEMIA EXTEND

MINOCA-BAT

CABG-PCI-SHOCK

In Progress

ISCHEMIA-Heart Failure Planning Study


ISCHEMIA EXTEND

The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) and the ISCHEMIA-Chronic Kidney Disease (CKD) trial EXTENDed Follow-up (EXTEND) is the proposed long-term follow-up of randomized, surviving participants in the ISCHEMIA and ISCHEMIA-CKD trials. The long-term follow-up will assess whether an initial invasive strategy—cardiac catheterization and revascularization when feasible plus optimal medical therapy (OMT)—reduces long-term all-cause mortality as compared with an initial conservative strategy of OMT for stable ischemic heart disease patients with moderate or severe ischemia.

Results from the proposed EXTEND study will tell us if heart disease patients with abnormal stress tests live longer if they have treatment on their narrowed arteries with surgery or stents in addition to medication and healthier lifestyle. This research will also help doctors and scientists create a score to predict how long people with heart disease will live based on things like kidney function and type of heart attack they may have had. This information should help guide doctors and researchers who treat and study patients with heart disease to improve the health of these patients.


MINOCA-BAT

The ISCHEMIA Clinical Coordinating Center at NYU is currently planning for a new study! Drs. Harmony Reynolds and Judith Hochman are pleased to introduce the MINOCA-BAT randomized trial. This study is a 2 x 2 factorial trial of beta blockade, ACE inhibitors/ angiotensin receptor blockers, both or neither in patients with myocardial infarction with non-obstructive coronary artery disease, or MINOCA. MINOCA-BAT will be a global collaborative clinical trial, with the overall effort led by Dr. Bertil Lindahl at Uppsala University and the North American trial effort led by Drs. Reynolds and Hochman, with collaboration from Dr. Shaun Goodman as Canadian country leader.

What is MINOCA? MINOCA is MI meeting the universal definition in patients who have less than 50% stenosis on angiography in all major epicardial vessels, without an alternative explanation for the MI presentation. For MINOCA-BAT, the left ventricular ejection fraction must be ≥40%. An American Heart Association Scientific Statement on the definition and evaluation of MINOCA was recently published: https:// www.ahajournals.org/doi/10.1161/CIR.0000000000000670

Who will be asked to participate? ISCHEMIA sites who see patients with MINOCA in the United States and Canada. Sites in Europe may also be able to participate – please contact the CCC for further information.

Are opportunities available to contribute to the proposed trial? Pilot data are currently being collected through surveys. We may reach out to your site to participate in the collection of pilot data and to request a letter of support which will be included in our upcoming grant application.

When will MINOCA-BAT start? The trial is already underway in Sweden and Australia. We anticipate that recruitment in North America will start at the beginning of 2021. Interested in learning more? Please contact us at MINOCA-BAT@nyulangone.org to learn more about this exciting upcoming trial


CABG-PCI-SHOCK

Myocardial infarction complicated by cardiogenic shock is associated with high mortality and is the main reason patients die with MI. The 35-45% 30-day mortality rate with PCI has persisted for decades despite advances in anti-thrombotic pharmacology, use of left ventricular support, and PCI techniques. Multi-vessel PCI in patients with MI and cardiogenic shock results in higher mortality compared with PCI of the culprit lesion only. Non-randomized studies, including SHOCK trial data, suggest potential benefit from complete revascularization and cardioprotective measures employed with CABG in patients with multi-vessel CAD and cardiogenic shock. We are planning a multicenter, randomized trial of initial infarct-only PCI for rapid reperfusion versus multi-vessel CABG immediately after cardiac catheterization with/without percutaneous infarct-related artery (IRA) reperfusion (such as balloon angioplasty and/or mechanical thrombectomy) in patients with MI, multi-vessel CAD, and cardiogenic shock. Participants in both groups may undergo placement of a LV support device of choice, and those randomly assigned to initial infarct-only PCI may have staged non-IRA PCI at a later date. For trial planning purposes we would appreciate your participation in a brief 5-minute internet-based survey (http://is.gd/CABG_SHOCK) to determine contemporary management of cardiogenic shock and to assess the feasibility of the proposed multi-center trial. Participation in the survey is voluntary. Your responses to the questions will help guide study design and may be considered during site selection for trial participation. Click on the link to participate: http://is.gd/CABG_SHOCK


ISCHEMIA-Heart Failure Planning Study

The ISCHEMIA Clinical Coordinating Center at NYU is currently planning for a new study! Drs. Stuart Katz, Judith Hochman, and Sripal Bangalore are pleased to introduce the ISCHEMIA-Heart Failure planning study funded by NHLBI (R34 HL141621-01A1). This study will explore the feasibility of conducting a future randomized clinical trial to evaluate revascularization strategies in patients with ischemic cardiomyopathy and reduced left ventricular ejection fraction.

Who will be asked to participate? ISCHEMIA sites that have reported onsite PCI and CABG capabilities. Are opportunities available to contribute to the proposed trial? Pilot data are currently being collected through various methods, such as interviews and surveys, and from a variety of sources, including industry experts, ISCHEMIA sites, and patients. We may reach out to your site to participate in the collection of pilot data as these opportunities arise. How will we use the pilot data? All pilot data collected will be used to optimize study design for a future international multisite clinical trial to compare the effects of myocardial revascularization with coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) on clinical outcomes in patients with ischemic cardiomyopathy with reduced ejection fraction. Interested in learning more? Please contact us at ISCHEMIA-HF@nyulangone.org to learn more about this exciting pilot study.