Stellate Ganglion Blockade to Reduce Cardiac Anxiety and PTSD Symptoms in Cardiac Arrest Survivors

NCT04582396 | Terminated Results DMC

• 2 other identifiers: AAAS83055P30AG064198-02
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot randomized controlled trial (RCT) to gain preliminary evidence regarding the acceptability, tolerability, safety, and efficacy of a combined intervention of Stellate Ganglion Blockade (SGB) and psychoeducation on trauma symptoms and health behaviors in patients exhibiting early PTSD symptoms after cardiac arrest (CA). Primary Aim 1 (Feasibility outcomes): Gain preliminary evidence regarding the acceptability, tolerability, and safety of conducting a randomized trial that evaluates a single SGB treatment in conjunction with psychoeducation among CA patients with early PTSD symptoms. Secondary Aim 1 (Treatment-related outcomes): Test, whether SGB/psychoeducation treatment in CA patients with clinically significant PTSD symptoms is associated with reduced cardiac anxiety, PTSD symptoms, and improved health behaviors (physical activity and sleep duration), assessed objectively by a wrist-worn accelerometer for 4 weeks post-discharge.

Conditions

PTSD; Cardiac Arrest; Anxiety and Fear; Sleep Disturbance; Health Behavior

Outcome Measures

Primary Outcomes (8)

• Proportion of Eligible Subjects Who Get Enrolled in the Trial

  This is designed to measure the feasibility of successful enrollment.

  Baseline (pre-procedure)

• Number of Patients Recruited Per Month

  This is designed to measure the rate of enrollment, with \<4 patients/month considered not meeting outcome

  Assessed at 10 Month from the beginning of enrollment

• Proportion of Participants Who Complete the 4-weeks Assessments

  This is designed to assess the short-term attrition and lost to follow-up up to 4 weeks post-enrollment.

  4 weeks post-enrollment

• Proportion of Participants Who Complete the 12-weeks Assessments

  This is designed to assess the long-term attrition and lost to follow-up up to 12 weeks post-enrollment.

  12-weeks post-procedure

• Horner's Syndrome

  Horner syndrome is a condition that affects the face and eye on one side of the body, being caused by a disrupted nerve pathway from the brain to the head and neck. This syndrome can be assessed through a visual exam, involving the observation of decreased pupil size, a drooping eyelid and decreased sweating on the affected side of the face.

  Immediately post-procedure

• Treatment Expectancy Eligibility Questionnaire

  This is a questionnaire that assesses the number of participants with credibility. Through this questionnaire, whether the participant will proceed through the study will be determined.

  Immediately post-procedure

• The Proportion of Participants Completing the Check-list of Various Components of Psychoeducation

  This is designed to assess the feasibility of administering psychoeducation, with \>80% of the components in the checklist as a threshold for success.

  Assessed at baseline post-procedure

• Total Actigraph Wear Time

  the proportion of participants with \>80% of the total actigraph wear time. It is designed to assess the acceptability of actigraphy

  Assessed at 4-weeks post-procedure

Secondary Outcomes (6)

• Number of Participants With Posttraumatic Stress Disorder Using Posttraumatic Stress Disorder (PCL-5)

  Assessed pre-procedure and then repeated at 4-weeks post-procedure

• The Proportion of Participants With Clinically Significant Symptoms of Cardiac Anxiety

  Assessed pre-procedure and then repeated at 4-weeks post-procedure

• The Proportion of Participants With Clinically Significant Symptoms of Generalized Anxiety Disorder.

  Assessed pre-procedure and then repeated at 4-weeks post-procedure

• The Proportion of Participants With Clinically Significant Symptoms of Depression.

  Assessed pre-procedure and then repeated at 4-weeks post-procedure

• The Proportion of Participants With Moderate to High Levels of Physical Activity.

  Assessed at 4-weeks post-discharge

Study Arms (2)

Stellate Ganglion Block + Psychoeducation

EXPERIMENTAL

For the active SGB arm, 7 to 8 mL of ropivacaine, 0.5%, will be injected around and into the site of the ganglion once before the hospital discharge. They will also receive a 30 minutes session of psychoeducation by a health professional with experience working with CA patients.

Procedure: stellate ganglion block injection; Behavioral: Psychoeducation

Normal saline injection + Psychoeducation

PLACEBO COMPARATOR

For the sham procedure, 1 to 2 mL of preservative-free normal saline will be injected into deep musculature in the neck. They will also receive a 30 minutes session of psychoeducation by a health professional with experience working with CA patients.

Procedure: Normal saline injection; Behavioral: Psychoeducation

Interventions

stellate ganglion block injection PROCEDURE

A stellate ganglion block (SGB) is an injection of local anesthetic (numbing medicine) to block the nerves located on either side of the voice box in the neck. It will be administered in an inpatient monitored setting.

Also known as: SGB injection

Stellate Ganglion Block + Psychoeducation

Normal saline injection PROCEDURE

An injection of normal saline will be injected into muscle on either side of the voice box in the neck. It will be administered in an inpatient monitored setting.

Also known as: Sham procedure

Normal saline injection + Psychoeducation

Psychoeducation BEHAVIORAL

The session will be 30 minutes in duration, to be administered by a health professional with experience working with CA patients, the goal will be to establish rapport and help patient identify anxious situations, thoughts, and bodily feelings related their recent CA that could lead to avoidant behavior. Explain how many of these feelings are common in CA survivors, and they are often unrelated to their risk of its recurrence. Explain how the body has a fight-or-flight system that is controlled in part by the stellate ganglion and explain how blocking the action of this part of the body can reduce the feelings of anxiety that commonly occur. Discuss how certain activities such as exercise can increase feelings of anxiety around bodily sensations, but continued engagement could reduce that fear and that exercise is helpful for recovering from CA

Normal saline injection + Psychoeducation; Stellate Ganglion Block + Psychoeducation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Fluent in English or Spanish
• A diagnosis of cardiac arrest (CA)
• Admitted to the New York-Presbyterian Hospital
• Elevated symptoms of psychological distress a. PCL-5 \> 32 with a minimum of 2 weeks after cardiac arrest

You may not qualify if:

• A prior SGB treatment
• Severe brain injury defined as Cerebral Performance Category Score ≥3, and/or significant aphasia, dysarthria, or cognitive impairment precluding ability to complete study questionnaires as determined by interviewer
• Terminal non-cardiovascular illness (life expectancy \<1 year)
• Severe mental illness requiring urgent psychiatric hospitalization
• Alcohol or substance abuse that would impede ability to complete study
• Unavailable for telephone and in-person follow-up
• Allergy to amide local anesthetics (e.g., ropivacaine, bupivacaine)
• Pre-existing Horner's syndrome
• Pregnancy
• Current anticoagulant use
• History of a bleeding disorder
• Infection or mass at injection site

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Columbia University Medical Center/New York Presbyterian

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Heart Arrest; Anxiety Disorders; Parasomnias; Health Behavior

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Heart Diseases; Cardiovascular Diseases; Sleep Wake Disorders; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

The study did not reach the target enrollment and therefore was inconclusive for treatment-related outcomes. This would need to be addressed in a future study in an outpatient setting because we learned that a majority of the inpatients were prescribed anticoagulants while in the hospital, which rendered them ineligible for the study.

Results Point of Contact

• Title: Dr. Sachin Agarwal
• Organization: Columbia University

sa2512@cumc.columbia.edu

2123421335

Study Officials

• Sachin Agarwal, MD, MPH

  Columbia University/New York Presbyterian

  PRINCIPAL INVESTIGATOR

• Ian M Kronish, MD, MPH

  Columbia University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In addition to the unblinded coordinator, and due to the nature of the study treatment, the person performing the procedure cannot be blinded (i.e. the person performing the procedure needs to assess the effectiveness of the block objective physical signs and symptoms), but is encouraged not to disclose the allocation to the patient or outcome assessors either before or after the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology, Department of Neurology

Model Details: This is a pilot RCT to gain preliminary evidence regarding the acceptability, tolerability, safety, and efficacy of a combined intervention of Stellate Ganglion Blockade and psychoeducation vs sham-procedure and psychoeducation on trauma symptoms and health behaviors in patients exhibiting early PTSD symptoms after cardiac arrest.

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 9, 2020
• Study Start: March 11, 2021
• Primary Completion: April 19, 2021
• Study Completion: April 19, 2021
• Last Updated: July 31, 2024
• Results First Posted: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available on August 1, 2021, and will be available until August 1, 2025.
• Access Criteria: For whom: Researchers who provide a methodologically sound protocol. For what analyses: To achieve aims in the approved protocol.

Locations

US (1)