Clinical trial NCT04582396: Stellate Ganglion Blockade to Reduce Cardiac Anxiety and PTSD Symptoms in Cardiac Arrest Survivors
Official title: A Pilot Study of Stellate Ganglion Blockade + Psychoeducation to Reduce Cardiac Anxiety and PTSD Symptoms in Cardiac Arrest Survivors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: PTSD
Cardiac Arrest
Anxiety and Fear
Sleep Disturbance
Health Behavior
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-10-09
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Every year in the U.S., 500,000 people experience sudden cardiac arrest (CA), caused by electrical disturbances across cardiac tissue, leading to marked arrhythmia that ultimately results in the heart ceasing to pump blood to the brain, lungs, and other organs. Due to advances in bundled post-arrest care, cardio-cerebral resuscitation, and effective cooling protocols, a substantial proportion of patients who receive guideline-based care (nearly 1 in 3 for out-of-hospital and \~50% for in-hospital CA) now survive this once universally fatal condition. While most survivors retain their cognitive function and physical independence, many grapple with CA's psychological consequences in the context of learning that they were "clinically dead."

In particular, many describe the CA experience as traumatic, and up to 1 in 3 CA survivors subsequently develop posttraumatic stress disorder (PTSD). Not only is PTSD common in CA patients, but there is evidence that PTSD after CA may influence health behaviors and prognosis.

Treatment of early PTSD and cardiac anxiety symptoms after CA requires timely intervention. Recent studies show that SGB is a safe and acceptable intervention for reducing PTSD symptoms in combat veterans. SGB treatment has never been tested to treat PTSD induced by acute medical events such as CA.

Eligibility criteria: Inclusion criteria

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

Exclusion criteria

1. A prior SGB treatment
2. 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
3. Terminal non-cardiovascular illness (life expectancy \<1 year)
4. Severe mental illness requiring urgent psychiatric hospitalization
5. Alcohol or substance abuse that would impede ability to complete study
6. Unavailable for telephone and in-person follow-up
7. Allergy to amide local anesthetics (e.g., ropivacaine, bupivacaine)
8. Pre-existing Horner's syndrome
9. Pregnancy
10. Current anticoagulant use
11. History of a bleeding disorder
12. Infection or mass at injection site

Primary outcomes:
measure: Proportion of Eligible Subjects Who Get Enrolled in the Trial
timeFrame: Baseline (pre-procedure)
measure: Number of Patients Recruited Per Month
timeFrame: Assessed at 10 Month from the beginning of enrollment
measure: Proportion of Participants Who Complete the 4-weeks Assessments
timeFrame: 4 weeks post-enrollment
measure: Proportion of Participants Who Complete the 12-weeks Assessments
timeFrame: 12-weeks post-procedure
measure: Horner's Syndrome
timeFrame: Immediately post-procedure
measure: Treatment Expectancy Eligibility Questionnaire
timeFrame: Immediately post-procedure
measure: The Proportion of Participants Completing the Check-list of Various Components of Psychoeducation
timeFrame: Assessed at baseline post-procedure
measure: Total Actigraph Wear Time
timeFrame: Assessed at 4-weeks post-procedure
Secondary outcomes:
measure: Number of Participants With Posttraumatic Stress Disorder Using Posttraumatic Stress Disorder (PCL-5)
timeFrame: Assessed pre-procedure and then repeated at 4-weeks post-procedure
measure: The Proportion of Participants With Clinically Significant Symptoms of Cardiac Anxiety
timeFrame: Assessed pre-procedure and then repeated at 4-weeks post-procedure
measure: The Proportion of Participants With Clinically Significant Symptoms of Generalized Anxiety Disorder.
timeFrame: Assessed pre-procedure and then repeated at 4-weeks post-procedure
measure: The Proportion of Participants With Clinically Significant Symptoms of Depression.
timeFrame: Assessed pre-procedure and then repeated at 4-weeks post-procedure
measure: The Proportion of Participants With Moderate to High Levels of Physical Activity.
timeFrame: Assessed at 4-weeks post-discharge
measure: The Proportion of Participants With Reduced Duration of Sleep.
timeFrame: Assessed at 4-weeks post-discharge
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center/New York Presbyterian
state: New York
Study officials:
affiliation: Columbia University/New York Presbyterian
name: Sachin Agarwal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Ian M Kronish, MD, MPH
role: STUDY_DIRECTOR
References: