Clinical trial NCT04648306: Restore EF Observational Study
Official title: Restore EF Observational Study (in High-risk PCI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Unstable Angina
Angina, Stable
NSTEMI - Non-ST Segment Elevation MI
Keywords: Impella
Hemodynamic Mechanical Support
Left ventricular ejection fraction
Surgical turndown
High Risk PCI
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-01
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who meet all the inclusion criteria and none of the exclusion criteria will be enrolled in the study.

Patients in whom prophylactic hemodynamic support with Impella was used during a non-emergent PCI will be evaluated for study participation at 60 days post index PCI procedure with Impella. In this study the index procedure is designated as Impella Protected PCI (ProPCI). Patients with cardiogenic shock and/or ST elevation myocardial infarction (STEMI) at the time of Impella initiation will not be included in this study.

Brief summary: A multi-center, prospective, observational, non-interventional single arm, study of the intermediate-term clinical outcomes collected from electronic health records of high-risk patients which have previously undergone standard of care prophylactic Impella support for a non-emergent percutaneous coronary intervention (PCI).

Detailed description: 1. Hypothesis The prophylactic use of Impella 2.5 or CP heart pumps during a non-emergent PCI in hemodynamically stable patients at high-risk for periprocedural complications during the procedure is associated with a significant improvement in the patient's LVEF and clinical status (heart failure symptoms and hospital readmissions) in the intermediate-term follow-up period post-ProPCI
2. Objectives The primary objective of this study is to assess the patient's LVEF at 90 days post-ProPCI (60 to 180 days window) as assessed in routine clinical practice and collected from EHR by clinical investigators.

   The secondary objective of the study is to assess the potential association between the completeness of revascularization and the clinical status at 90 days post-ProPCI (60-180 days window). Clinical status includes NYHA heart failure functional class and hospital readmission.
3. Sample Size: The study will enroll more than 1,000 patients at up to 30 investigational sites with experienced Impella operators (≥ 25 cases).
4. Primary Endpoint: Subject's LVEF at 90 days post-ProPCI (60 to 180 days window) collected from the subject's EHR.
5. Secondary Endpoints:

   * Completeness and extent of revascularization
   * NYHA functional class at 90 days post-ProPCI (60 to 180 days window)
   * Readmission at 90 days post-ProPCI (60 to 180 days window)

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Subject has previously undergone (≥ 60 days) an Impella Protected PCI (ProPCI) at a study site as identified in the Impella quality (IQ) assurance database (patients who expired or were lost to follow-up prior to opening of the follow-up study window (day 60 post Impella protected PCI) will not be included in the study

Exclusion Criteria:

* Subject with cardiogenic shock at the time of Impella insertion. Cardiogenic shock defined as: systemic hypotension (systolic blood pressure (SBP) \<90 mmHg or the need for inotropes/pressors to maintain a SBP \>90mmHg)
* Subject with ST elevation myocardial infarction at the time of Impella insertion.
* Subject underwent coronary bypass surgery after the index Impella ProPCI
* Subject underwent repeat revascularization with PCI after the index Impella ProPCI
* Subject underwent other cardiac procedures including valve therapies (surgical or percutaneous) after the index Impella ProPCI
* Subject underwent cardiac resynchronization therapy (CRT) initiated after the index Impella ProPCI
* Any known medical condition with a life expectancy \<6 months

Primary outcomes:
measure: Left ventricular ejection fraction (LVEF)
timeFrame: 90 days post Protective PCI (60 to 180 days window)
Secondary outcomes:
measure: Survival Rate
timeFrame: 90 days post Protected PCI (60 to 180 days window)
measure: NYHA Functional Class
timeFrame: 90 days post Protected PCI (60 to 180 days window)
measure: Readmission
timeFrame: 90 days post Protected PCI (60 to 180 days window)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Medical Center
state: Arizona
city: Tucson
country: United States
facility: Tucson Medical Center
state: Arizona
city: Fayetteville
country: United States
facility: Washington Regional Medical Center
state: Arkansas
city: North Little Rock
country: United States
facility: Arkansas Cardiology P.A.
state: Arkansas
city: Springdale
country: United States
facility: Northwest Medical Center
state: Arkansas
city: Loma Linda
country: United States
facility: Loma Linda University Medical
state: California
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: Daytona Beach
country: United States
facility: Advent Health
state: Florida
city: Skokie
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Davenport
country: United States
facility: Genesis Medical Center
state: Iowa
city: Lexington
country: United States
facility: Baptist Healthcare System
state: Kentucky
city: Houma
country: United States
facility: Lafayette General Medical Center
state: Louisiana
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Saint Cloud
country: United States
facility: St. Cloud Hospital
state: Minnesota
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Greenville
country: United States
facility: Vidant Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Arlington
country: United States
facility: Presbyterian Hospital Dallas
state: Texas
city: Kingwood
country: United States
facility: Kingwood Medical Center
state: Texas
city: Norfolk
country: United States
facility: Sentara Healthcare
state: Virginia
Study officials:
affiliation: Saint Cloud Hospital
name: Thom Dahle, MD
role: STUDY_CHAIR
affiliation: Providence Health & Services
name: Jason Wollmuth, MD
role: STUDY_CHAIR
affiliation: East Carolina University
name: Lynn Morris, MD
role: STUDY_CHAIR
affiliation: NYU Langone
name: Craig Thompson, MD
role: STUDY_CHAIR
References: