Revascularization Procedures for Coronary Artery Disease
(RECHARGE:M Trial)
Recruiting in Palo Alto (17 mi)
+13 other locations
Overseen byMario Gaudino, MD, PhD, MSCE, FEBCTS, FACC
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Weill Medical College of Cornell University
Disqualifiers: Recent MI, Cardiogenic shock, Pregnancy, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This is a research study in minorities to compare the outcomes of two procedures that restore blood flow to the arteries of the heart. In one procedure the blockages are ballooned and then stented with a small wire mesh tube through a small incision in the wrist or the groin. The other procedure is an open-heart operation in which healthy blood vessels from inside the chest, leg, and/or forearm are used to "bypass" the blockages (like a detour). Outcomes will be measured by comparing survival and improvement in quality-of-life.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of this treatment for coronary artery disease?
Research shows that for patients with multiple blocked heart arteries, coronary artery bypass grafting (CABG) often leads to better long-term survival compared to percutaneous coronary intervention (PCI), which includes procedures like stenting.
12345Is coronary revascularization generally safe for humans?
Coronary revascularization procedures like coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) have been widely studied and are generally considered safe, though they can have some risks. Studies show that adverse events can occur, but these procedures are well-established for treating coronary artery disease and acute coronary syndromes.
678910How is the treatment of coronary artery disease with CABG and PCI different from other treatments?
CABG (Coronary Artery Bypass Grafting) and PCI (Percutaneous Coronary Intervention) are unique because they are surgical procedures specifically designed to improve blood flow to the heart. CABG is often used for more complex cases involving multiple blocked arteries, while PCI is typically used for single blockages and involves less invasive techniques like stenting. These treatments are chosen based on the specific needs of the patient and the complexity of their coronary artery disease.
1112131415Eligibility Criteria
The RECHARGE trial is for minority individuals at least 18 years old with multivessel or left main coronary artery disease (CAD), where a heart team believes both stenting and bypass surgery could work. Participants must be able to give consent and complete quality-of-life questionnaires.Inclusion Criteria
I identify as a member of a minority group.
I am 18 years old or older.
I have been diagnosed with severe coronary artery disease and am considered for surgery or stenting.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo either CABG or PCI procedures to restore blood flow to the heart
1 month
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
5-10 years
Telephone follow-up at 30 days, 3 months, 6 months, and every 6 months through 36 months, then annually
Annual Assessment
Annual assessments including echocardiogram and blood tests for serum creatinine, hemoglobin, and lipids
Annually
1 visit (in-person or outpatient)
Participant Groups
This study compares two heart procedures in minorities: one uses stents to open blockages via an incision in the wrist or groin, while the other is open-heart surgery using vessels from elsewhere in the body to bypass blockages.
2Treatment groups
Experimental Treatment
Group I: RECHARGE: Minorities - PCIExperimental Treatment1 Intervention
Group II: RECHARGE: Minorities - CABGExperimental Treatment1 Intervention
Coronary artery bypass grafting is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:
🇺🇸 Approved in United States as CABG for:
- Coronary artery disease
- Heart failure
- Angina pectoris
🇪🇺 Approved in European Union as CABG for:
- Coronary artery disease
- Heart failure
- Angina pectoris
🇨🇦 Approved in Canada as CABG for:
- Coronary artery disease
- Heart failure
- Angina pectoris
🇯🇵 Approved in Japan as CABG for:
- Coronary artery disease
- Heart failure
- Angina pectoris
🇨🇳 Approved in China as CABG for:
- Coronary artery disease
- Heart failure
- Angina pectoris
🇨🇭 Approved in Switzerland as CABG for:
- Coronary artery disease
- Heart failure
- Angina pectoris
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Emory UniversityAtlanta, GA
Ascension St. Vincent Cardiovascular Research InstituteCarmel, IN
Massachusetts General HospitalBoston, MA
Englewood HospitalEnglewood, NJ
More Trial Locations
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Who Is Running the Clinical Trial?
Weill Medical College of Cornell UniversityLead Sponsor
Patient-Centered Outcomes Research InstituteCollaborator
Icahn School of Medicine at Mount SinaiCollaborator
References
Composite outcomes in coronary bypass surgery versus percutaneous intervention. [2021]Recent observational studies show that patients with multivessel coronary disease have a long-term survival advantage with coronary artery bypass grafting (CABG) compared with percutaneous coronary intervention (PCI). Important nonfatal outcomes may also affect optimal treatment recommendation.
Comparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease. [2010]The recent recognition that coronary-artery stenting has improved the short- and long-term outcomes of patients treated with angioplasty has made it necessary to reevaluate the relative benefits of bypass surgery and percutaneous interventions in patients with multivessel disease.
Outcomes of coronary artery bypass grafting versus percutaneous coronary intervention with drug-eluting stents for patients with multivessel coronary artery disease. [2010]Advances in coronary artery bypass grafting (CABG) surgery and percutaneous coronary intervention (PCI) with drug-eluting stents have dramatically improved results of these procedures. The optimal treatment for patients with multivessel coronary artery disease is uncertain given the lack of prospective, randomized data reflecting current practice. This study represents a "real-world" evaluation of current technology in the treatment of multivessel coronary artery disease.
Revascularization in Patients With Multivessel Coronary Artery Disease and Severe Left Ventricular Systolic Dysfunction: Everolimus-Eluting Stents Versus Coronary Artery Bypass Graft Surgery. [2022]Guidelines recommend coronary artery bypass graft surgery (CABG) over percutaneous coronary intervention (PCI) for multivessel disease and severe left ventricular systolic dysfunction. However, CABG has not been compared with PCI in such patients in randomized trials.
Systematic review: the comparative effectiveness of percutaneous coronary interventions and coronary artery bypass graft surgery. [2022]The comparative effectiveness of coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI) for patients in whom both procedures are feasible remains poorly understood.
Minimally invasive direct coronary artery bypass graft surgery or percutaneous coronary intervention for proximal left anterior descending artery stenosis: a meta-analysis. [2018]We conducted a metaanalysis comparing early and midterm cardiovascular adverse events associated with minimally invasive direct coronary artery bypass graft surgery (MIDCABG) and percutaneous coronary intervention (PCI), with a focus on drug-eluting stents (DES).
Comparison of one-year outcomes of percutaneous coronary intervention versus coronary artery bypass grafting in patients with unprotected left main coronary artery disease and acute coronary syndromes (from the CUSTOMIZE Registry). [2011]Uncertainty surrounds the optimal revascularization strategy for patients with left main coronary artery disease presenting with acute coronary syndromes (ACSs), and adequately sized specific comparisons of percutaneous and surgical revascularization in this scenario are lacking. The aim of this study was to evaluate the incidence of 1-year major adverse cardiac events (MACEs) in patients with left main coronary artery disease and ACS treated with percutaneous coronary intervention (PCI) and drug-eluting stent implantation or coronary artery bypass grafting (CABG). A total of 583 patients were included. At 1 year, MACEs were significantly higher in patients treated with PCI (n = 222) compared to those treated with CABG (n = 361, 14.4% vs 5.3%, p
Superior long term outcome associated with native vessel versus graft vessel PCI following secondary PCI in patients with prior CABG. [2017]Secondary percutaneous coronary intervention (PCI) in patients with prior coronary artery bypass graft surgery is increasingly common. Graft vessel PCI has higher rates of adverse events compared with native coronary vessel PCI.
[Percutaneous and surgical revascularization in acute coronary syndromes without persistent ST segment elevation. One-year outcome of 361 patients assigned to early invasive strategy]. [2010]Percutaneous coronary interventions (PCI) and coronary artery bypass grafting (CABG) are well established revascularization methods in stable coronary artery disease and in acute coronary syndromes (ACS) as well.
Adverse events after coronary revascularization procedures in California 2000 to 2010. [2013]Public reporting of coronary artery bypass grafting (CABG) mortality in California was initiated in 2003. Drug-eluting stents were widely introduced in the same year. Adverse events after percutaneous coronary intervention (PCI) and CABG were analyzed to study the impact of these events. Annual California hospital discharge data were collected from 2000 through 2010. In-hospital mortality and hospital readmission for adverse events 6,000 adverse events by the end of the decade.
[Bypass surgery vs angioplasty for coronary artery disease]. [2015]Revascularization techniques such as coronary angioplasty or coronary artery bypass surgery play a growing role in the management of coronary artery disease. Angioplasty is the treatment of choice for single coronary lesions while surgery remains the best approach for the revascularization of multivessel disease. There are some exceptions to this rule, however. Bypass surgery may be recommended for the revascularisation of proximal left anterior descending lesions and, of course, for isolated left main stenosis. On the opposite, coronary angioplasty and stenting is used more frequently in the treatment of multivessel lesions amenable to this technique. Choice of either method of revascularization is pragmatic, based on clinical, anatomical and physiological considerations and organized in the setting of a medicosurgical collaboration.
Robotic CABG and Hybrid Approaches: The Current Landscape. [2015]Modern treatment of coronary artery disease (CAD) requires a patient-centered approach. With several technological advances, the options for treatment must be carefully weighed and novel approaches tested for safety and efficacy. In this chapter, we outline some of the new approaches available to cardiac surgeons for the treatment of CAD, including off pump coronary artery bypass grafting, minimally invasive as well as hybrid and robotic coronary revascularization. We discuss current evidence and controversies, and highlight the future directions and challenges in the field of surgical coronary revascularization.
Advances in the surgical treatment of coronary artery disease. [2005]Several new surgical approaches to coronary artery disease revascularization have been developed to avoid the adverse effects associated with conventional coronary bypass graft surgery and the use of cardiopulmonary bypass. This article describes some of these approaches, including minimally invasive direct coronary artery bypass graft surgery, port access surgery, hybrid of integrated coronary revascularization, radial artery and endoscopic vein harvesting, and transmyocardial revascularization. This article also identifies the nursing considerations for each of these surgeries.
Newer surgical techniques in myocardial revascularization. [2004]Recent trends in the patient population coming for surgical treatment of coronary artery disease have prompted alterations in the type of coronary artery bypass surgery performed. Emphasis is placed on the more widespread use of arterial grafts and revascularization of vessels with extensive distal disease, utilizing endarterectomy techniques, in an attempt to provide a more complete and long-lasting revascularization.
[Surgical treatment in coronary heart disease (author's transl)]. [2019]This paper describes the operative techniques appropriate to the treatment of coronary heart disease. The chapters deal with general preliminaries and indications for surgery, the selection of bypass material, surgical instruments for coronary opertaions, the methods of extracorporeal circulation, the distal coronary anastomosis, the proximal aortal anastomosis, intraoperative monitoring of results, intra- and postoperative myocardinal infarction, the fate of venous bypass grafts, operative treatment of the ruptured ventricular septum and papillary muscle, and ventricular aneurysmectomy.