Is NCT06964685 recruiting in Detroit, MI?

Yes, NCT06964685 is currently recruiting participants at its Detroit, MI location. This ami cardiogenic shock clinical trial is actively enrolling qualified participants.

How do I join the ami cardiogenic shock clinical trial in Detroit?

To join this clinical trial in Detroit, 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 Detroit 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.

AMI Cardiogenic Shock Clinical Trial in Detroit, MI

About This AMI Cardiogenic Shock Study in Detroit

The observational study titled "Observational Assessment of Support with Impella Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock (OASIS-AMICS)" aims to evaluate the safety outcomes of patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) who receive Impella CP during percutaneous coronary intervention (PCI) and who are managed with Impella best practices while receiving guideline-directed standard of care. This prospective, multicenter study will enroll up to 350 hemodynamically unstable patients with cardiogenic shock of less than 12 hours duration and acute myocardial infarction (AMI) of less than 24 hours duration. Cardiogenic shock will be confirmed by tissue hypoperfusion (lactate ≥ 2.5mmol/L and/or SvO2 \<55% with a normal PaO2) and systolic blood pressure \<100 mmHg and/or need for vasopressor therapy (dopamine/norepinepherine or epinephrine). Patients will be assessed for various safety endpoints, including a composite safety endpoint involving major bleeding, acute limb ischemia, and acute kidney injury. Secondary endpoints will evaluate all-cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE), and hospitalizations through 1-year post-Impella implant. All patients presenting with AMICS at study sites will be screened for inclusion in the study after hospital discharge (or after death, if prior to hospital discharge). IRB approved consent waiver will be used to collect data from electronic health records from; Impella placement to discharge and post-discharge at 30 days post-Impella implant, 6 months post-Impella implant, and 1 year post-Impella implant.

Sponsor: Abiomed Inc.

Who Can Participate

Inclusion Criteria

Acute myocardial infarction (AMI) of \<36 hours duration from symptom onset to cath lab arrival, confirmed by:

ECG and/or biomarker evidence of ST-segment elevation myocardial infarction (STEMI), STEMI equivalents, or new or presumed new left bundle branch block or

ECG and/or biomarker evidence of non-ST-segment elevation myocardial infarction (NSTEMI) and angiographic evidence of one or more culprit vessels

Cardiogenic shock confirmed by at least two of the following:

Tissue hypoperfusion, manifested by an arterial or venous blood lactate level ≥2.5 mmol/L or SvO2 \<55% in the presence of a PaO2 \> 90mmHg

Systolic blood pressure \<100 mmHg or need for vasoactive agents to maintain systolic blood pressure ≥100 mmHg

Hemodynamic criteria represented by a cardiac index of \<2.2 L/min/m\^2 or a cardiac power output ≤0.6 W

Cardiogenic shock that develops under one of the following conditions:

prior to primary PCI, with \<24 hours from the onset of shock to cath lab arrival, or

\<12 hours after initiating primary PCI

Patient was supported with Impella CP as the initial MCS device for cardiogenic shock

Age ≥18 years

Europe only: Subject or legally designated representative (LDR) or Independent Physician has provided written informed consent for participation in the observational study

Exclusion Criteria

Any contraindication listed in the Impella CP IFU if known to be present (i.e. mural thrombus in the left ventricle; presence of a mechanical aortic valve or heart constrictive device; aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less); moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); severe arterial disease precluding placement of the Impella system; presence of an atrial or ventricular septal defect (including post-infarct VSD); significant right heart failure; left ventricular rupture; cardiac tamponade; combined cardiorespiratory failure).

Shock principally due to a cause other than LV failure, including:

RV infarction, hypovolemia, anaphylaxis, hemorrhage, sepsis, myocarditis, pulmonary embolism, pneumothorax, or high cardiac output shock

Severe arrhythmias as the primary cause of low cardiac output, including acute bradyarrhythmias, tachyarrhythmias, or advanced heart block

Known mechanical complications of AMI that may cause cardiogenic shock such as free wall rupture, ventricular septal defect or papillary muscle rupture with acute mitral regurgitation

Procedural complication of the PCI that results in coronary perforation

Other mechanical circulatory support already in place for present indication, including intra-aortic balloon counter-pulsation or patients with Impella CP placement prior to transfer to the cath lab at the tertiary facility

Acute or chronic aortic dissection

Prior PCI at another institution for the present infarction

Thrombolytic therapy for the present infarction

Not obeying verbal commands after preadmission or in-hospital cardiac arrest, indicative of possible anoxic brain injury NOTE:

Non-intubated subjects: A positive and appropriate response to commands must be repeatable on at least two (2) instances to rule out reflex response to voice

Intubated subjects are excluded if: They were not following verbal commands immediately prior to intubation, or They were not clearly following verbal commands after intubation within 6 hours post-PCI

Infective endocarditis

Other severe, concomitant disease with limited life expectancy \<1 year (other than cardiogenic shock)

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

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 Detroit?

Yes, this clinical trial (NCT06964685) has an active research site in Detroit, MI 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.

AMI Cardiogenic Shock Treatment Options in Detroit, MI

If you're searching for ami cardiogenic shock treatment options in Detroit, MI, this clinical trial (NCT06964685) 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 Detroit research site is actively enrolling participants for this clinical trial. You'll receive care from experienced ami 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 ami cardiogenic shock clinical trials near you to find additional studies recruiting in your area.

AMI Cardiogenic Shock Clinical Trial in Detroit, MI

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