First U.S. Patient Randomized to CT-Guided PCI in P4 Research Trial Accelerating Innovation with Advanced Cardiovascular Imaging

Minneapolis Heart Institute Foundation® First in U.S. to Accelerate Innovation Through Research & Education using Advanced Cardiovascular Imaging
Aug 29, 2024

Minneapolis Heart Institute Foundation® (MHIF) announced the first enrollments in the Precise Procedural and PCI Plan (P4) Research Trial evaluating the potential for advanced cardiovascular imaging to enhance patient care. The first U.S. patients enrolled underwent computed tomography (CT) imaging with state-of-the-art 3D modeling provided by the trial as part of pre-procedure planning to guide the percutaneous coronary intervention (PCI) used to open a blockage in the heart. The P4 research trial is a global, multicenter, randomized trial comparing clinical outcomes between two imaging strategies to guide PCI: novel coronary computed tomography (CT)-guided PCI and standard intravascular ultrasound (IVUS)-guided PCI.

“We are pleased to complete the first enrollments in this study as we gather data on the potential for CT-guided PCIs to advance care and outcomes for patients undergoing these procedures,” said Dr. Yader Sandoval, co-chairman for MHIF’s Center for Coronary Artery Disease and P4 site principal investigator. “Our team of researchers has a depth of expertise in advanced cardiovascular imaging and we’re proud to be the first center in the United States with the capability and technology to evaluate the potential for this to continue to advance patient care.”

The first U.S. CT-guided PCI procedure for the P4 trial was performed by interventional cardiologists, Drs. Yader Sandoval & Emmanouil Brilakis, in collaboration with imaging cardiologists, Drs. John Lesser and João Cavalcante, all study investigators at MHIF. The study is sponsored by CoreAalst BV in Belgium under the leadership of Dr. Carlos Collet Bortone, P4 principal investigator.

CT-guided PCI is a procedure leveraging CT imaging to guide the intervention in treating coronary artery disease. In this procedure, CT scans are done prior to the procedure, providing detailed images of the coronary arteries and a clear understanding of the individual patient anatomy, extent and location of plaque and characteristics of the lesions. The use of advanced imaging informs the interventional procedure more precisely, likely optimizing stent or balloon placement and leading to enhanced long-term results for patients. Traditional PCI typically involves the use of X-ray imaging (fluoroscopy) to visualize the coronary arteries and guide the placement of stents or balloons to open narrowed or blocked arteries.

CT-guided PCI is especially helpful in complex cases where traditional imaging enhances 3D modeling detail, for example in patients with multiple or extensive plaque or calcification. This approach leverages the most advanced technologies and expertise that are not necessarily common or accessible in all centers today.

MHIF also held the first U.S. CT-guided PCI course for physicians in April 2024 and has plans to host future courses to train physicians in how to perform CT-guided PCI, including the CT for PCI 2.0 Course in October 24-25, 2024.

About the Center for Coronary Artery Disease

Coronary artery disease is the leading cause of death in the developed world. As part of its mission to create a world without heart and vascular disease, the Minneapolis Heart Institute Foundation® (MHIF) has built a reputation as one of the world’s most distinguished champions in the fight against coronary artery disease (CAD) and established its Center for Coronary Artery Disease.

Under the leadership of Dr. Emmanouil Brilakis, along with Drs. Yader Sandoval and Nicholas Burke, MHIF’s Center for Coronary Artery Disease works to decrease the burden of CAD through research, innovation and education. An internationally recognized research institute, MHIF is integrated with a high-quality, high-volume cardiovascular care center at Abbott Northwestern Hospital, which allows access to study and offer cutting-edge treatment to a large number of patients with CAD.

About the Minneapolis Heart Institute Foundation®

The Minneapolis Heart Institute Foundation (MHIF) strives to create a world without heart and vascular disease. To achieve this bold vision, MHIF is dedicated to improving the cardiovascular health of individuals and communities through innovative research and education.

Scientific Innovation and Research – MHIF is a recognized leader across all specialties of heart and vascular research. Each year, MHIF leads more than 220 research studies with more than 2,200 patients and publishes more than 250 articles to share learnings from research. MHIF research has improved the standard of care around the world through protocols like Level One for heart attack, which significantly improved outcomes and survival for patients.

Education and Outreach – MHIF provides more than 11,000 hours of education each year putting its research into practice to improve outcomes among health care providers. This commitment extends to patients and caregivers through community health and education events to raise awareness of heart care and research, engaging individuals in their own health.

The Minneapolis Heart Institute Foundation’s work is funded by generous donors and sponsors and engages in cutting-edge research initiatives with its physician partners from the Allina Health Minneapolis Heart Institute® at Abbott Northwestern Hospital and at 38 community sites across Minnesota and western Wisconsin. For more information, please visit mplsheart.org.

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The Minneapolis Heart Institute Foundation® (MHIF) strives to create a world without heart and vascular disease. To achieve this bold vision, we are dedicated to improving the cardiovascular health of individuals and communities through innovative research and education.

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