NCT01909895

Brief Summary

Study aims and hypotheses are as follows: Primary Hypotheses: Compared to the neutral condition, the anger recall task will acutely induce endothelial dysfunction by impairing endothelium-dependent arterial vasodilation (Hypothesis 1a); increasing circulating levels of EC-derived microparticles (EMPs), a marker of EC injury (Hypothesis 1b); and reducing circulating levels of bone marrow-derived endothelial progenitor cells (EPCs), a marker of EC reparative capacity (Hypothesis 1c). Secondary Hypotheses: Compared to the neutral condition, the depressed mood and separately the anxiety recall tasks will acutely impair endothelium-dependent arterial vasodilation, increase circulating levels of EMPs, and reduce circulating levels of bone marrow-derived EPCs. There will be a relation of the level of self-reported anger, depressed mood, and anxiety with endothelial dysfunction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

7.2 years

First QC Date

July 25, 2013

Last Update Submit

January 12, 2022

Conditions

EmotionsEndothelial Dysfunction

Outcome Measures

Primary Outcomes (15)

  • Endothelium-dependent arterial vasodilation

    baseline

  • Circulating EMPs expressing CD62E

    baseline

  • Circulating early EPCs (KDR+, CD34+, CD133+ cells)

    baseline

  • Endothelium-dependent arterial vasodilation

    3 mins after end of mood induction

  • Endothelium-dependent arterial vasodilation

    40 mins after end of mood induction

  • Endothelium-dependent arterial vasodilation

    70 mins after end of mood induction

  • Endothelium-dependent arterial vasodilation

    100 mins after end of mood induction

  • Circulating EMPs expressing CD62E

    3 mins after end of mood induction

  • Circulating EMPs expressing CD62E

    40 mins after end of mood induction

  • Circulating EMPs expressing CD62E

    70 mins after end of mood induction

  • Circulating EMPs expressing CD62E

    100 mins after end of mood induction

  • Circulating early EPCs (KDR+, CD34+, CD133+ cells)

    3 mins after end of mood induction

  • Circulating early EPCs (KDR+, CD34+, CD133+ cells)

    40 mins after end of mood induction

  • Circulating early EPCs (KDR+, CD34+, CD133+ cells)

    70 mins after end of mood induction

  • Circulating early EPCs (KDR+, CD34+, CD133+ cells)

    100 mins after end of mood induction

Secondary Outcomes (3)

  • Circulating EMPs expressing CD31

    baseline; 3 mins, 40 mins, 70 mins, 100 mins after end of mood induction

  • Circulating EMPs expressing CD51

    baseline; 3 mins, 40 mins, 70 mins, 100 mins after end of mood induction

  • Self-reported anger, depressed mood, and anxiety

    baseline; 3 mins, 40 mins, 70 mins, 100 mins after end of mood induction

Other Outcomes (2)

  • Nitric oxide(NO) inhibition

    baseline; 3 mins, 40 mins, 70 mins, 100 mins after end of mood induction

  • Stress response

    baseline; 3 mins, 40 mins, 70 mins, 100 mins after end of mood induction

Study Arms (4)

Anger induction

EXPERIMENTAL

The participant will be asked to undergo a validated anger induction task.

Other: Anger Induction

Depressed Mood Induction

EXPERIMENTAL

The participant will be asked to undergo a validated depression/sadness induction task.

Other: Depressed Mood Induction

Anxiety Induction

EXPERIMENTAL

The participant will be asked to undergo a validated anxiety induction task.

Other: Anxiety Induction

Neutral emotion task

OTHER

The participant will be asked to undergo a validated neutral task (i.e. count aloud by ones, starting with one and ending with 100, over and over, until the task period has ended).

Other: Neutral emotion task

Interventions

Anger InductionOTHER

The participant is asked to recall an incident in the recent past during which they became moderately to extremely angry, or is asked to read statements out loud evoking moderate to extreme feelings of anger. The participant is asked to take a few moments to bring the details of the incident to mind and, when ready, to describe the incident in great detail to the experimenter. Participants are asked to describe key elements, such as any dialogue that transpired during the incident, along with other details of the incident, particularly regarding the feelings of that particular emotion experienced at the time. In so doing, the experimenter works to re-elicit the emotions that accompanied the original incident. The duration of the negative emotion induction task is 8 minutes.

Anger induction
Depressed Mood InductionOTHER

The participant will be asked to undergo a validated depression/sadness induction task.

Depressed Mood Induction
Anxiety InductionOTHER

The participant will be asked to undergo a validated anxiety induction task.

Anxiety Induction
Neutral emotion taskOTHER

This is a neutral control task that each of the negation emotion induction tasks will be compared to.

Neutral emotion task

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and over
  • Fluent in English

You may not qualify if:

  • History of any chronic medical condition including prevalent CVD and traditional risk factors
  • Active smoking
  • Chronic medication use, including over-the-counter drugs or herbal medications
  • History of psychosis, a mood disorder, or any overt personality disorder
  • Latex allergy
  • Poor peripheral veins with low possibility of getting IV access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • Ensari I, Burg MM, Diaz KM, Fu J, Duran AT, Suls JM, Sumner JA, Monane R, Julian JE, Zhao S, Chaplin WF, Shimbo D. Putative mechanisms Underlying Myocardial infarction onset and Emotions (PUME): a randomised controlled study protocol. BMJ Open. 2018 May 31;8(5):e020525. doi: 10.1136/bmjopen-2017-020525.

    PMID: 29858417DERIVED

Study Officials

  • Daichi Shimbo, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 25, 2013

First Posted

July 29, 2013

Study Start

September 1, 2013

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

January 27, 2022

Record last verified: 2022-01

Locations

US(1)