Is NCT05485376 recruiting in Boston, MA?

Yes, NCT05485376 is currently recruiting participants at its Boston, MA location. This cardiogenic shock clinical trial is actively enrolling qualified participants.

How do I join the cardiogenic shock clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Cardiogenic Shock Clinical Trial in Boston, MA

About This Cardiogenic Shock Study in Boston

The primary objective of the PACCS trial is to assess if early invasive hemodynamic assessment and ongoing management with a PAC in patients with cardiogenic shock due to acutely decompensated heart failure (AHDF-CS) is associated with lower in-hospital mortality risk compared to the current standard of care with no or delayed PAC assessment.

Sponsor: Tufts Medical Center

Who Can Participate

Inclusion Criteria

Age ≥18 years and ≤90 years

Clinical heart failure presentation and left ventricular function as follows: Either 2A or 2B must be present A. Subject has de novo acute decompensated heart failure and shock with an LVEF ≤40% OR B. Subject has acute on chronic heart failure with a documented history of a LVEF ≤40% within 6 months of admission and a current LVEF ≤40% within 24 hours of screening during the current hospitalization. NOTE: The LVEF must be quantitatively measured as ≤ 40% by an echocardiogram within 24 hours of screening. If multiple echocardiograms have been performed within 24 hours, the most recent test must be used to qualify the patient.

Cardiogenic Shock (CS) defined by a lactate level ≥ 2.1 mmol/L and any 2 of the following parameters within 24 hours of screening:

SBP \<90 mmHg for more than 30 minutes from baseline SBP

Requires the use of at least 1 vasopressor or inotrope

Requires intra-aortic balloon pump (IABP) support

Presence of congestion on exam: JVP elevated, pulmonary edema on CXR or exam, dyspnea at rest, orthopnea, bendopnea, or worsening peripheral or abdominal swelling

Initial diagnosis of CS within 24 hours of screening at the enrolling site

Patient or legally authorized representative provides informed consent A HIPAA waiver for screening is requested to identify potential subjects. No recruitment materials will be given to potential subjects. No identifiable data will be retained for subjects that are determined to be ineligible

Exclusion Criteria

Primary etiology of shock other than systolic left heart failure including but not limited to: acute myocardial infarction, sepsis, hypovolemia, hemorrhage, severe anemia, primary RV failure, pulmonary embolism, or tamponade.

Patient has a durable ventricular assist device or temporary mechanical circulatory support (other than IABP) or PAC prior to enrollment

Actively listed for cardiac transplantation (Status 7 patients are eligible for the trial)

Patient transferred from another facility with a diagnosis of cardiogenic shock

Any known co-morbidity other than heart failure with anticipated survival \< 6 months

Pre-enrollment labs (any of the following): International Normalized Ratio (INR) \> 3, Platelet count \< 50k, Hemoglobin \< 7

Refractory or recurrent cardiac arrest (\>1 episode requiring defibrillation or cardiopulmonary resuscitation) within 24 hours prior to screening

DNR/ DNI status

Pregnancy, child-birth within 6 months, or lactation

Active infection documented by persistent fever (Temp \> 38.4oC within 24 hours of screening) or confirmed bacteremia

Implantation of PPM or ICD within past 3 months

Mechanical complication of AMI (ie VSD, papillary muscle rupture, flail mitral regurgitation, free wall rupture)

Anoxic brain injury

On renal replacement therapy prior to enrollment

Cardiac surgery within 3 months of current admission

Severe aortic, pulmonic, tricuspid stenosis or acute structural mitral regurgitation or infective endocarditis

History of cardiac amyloid

Congenital heart disease excluding the presence of a bicuspid aortic valve

Planned cardiac surgery during admission

World Health Organization (WHO) Group I, III, IV, or V pulmonary hypertension

Any known contraindication to PAC placement

Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint

Any medical or psychiatric condition such as dementia, alcoholism, or substance abuse which may preclude informed consent or interfere with any of the study procedures, including follow-up

Prior stroke with any permanent neurologic deficit or any prior intracranial hemorrhage or any prior subdural hematoma or known intracranial pathology pre-disposing to intracranial bleeding, such as an arteriovenous malformation or mass

Subject has previously hospitalized for COVID-19 unless he/she has been discharged and asymptomatic for ≥4 weeks

Subject is COVID-19 PCR/antigen positive within the prior 4 weeks

Subject belongs to a vulnerable population \[defined as individuals with mental disability, persons in nursing homes, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, members of the armed forces and persons kept in detention\]

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT05485376) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Cardiogenic Shock Treatment Options in Boston, MA

If you're searching for cardiogenic shock treatment options in Boston, MA, this clinical trial (NCT05485376) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced cardiogenic shock specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all cardiogenic shock clinical trials near you to find additional studies recruiting in your area.

Cardiogenic Shock Clinical Trial in Boston, MA

Expert Care in Boston

IRB Approved

No-Cost Care

Apply for This Boston Location

Why Participate?

Simple Process