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Psychological Challenges for Cardiovascular Health (CHARM Trial)

N/A

Recruiting

Led By Peter J Gianaros, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up mean sbps for the computation of change scores will be computed from the average of the 5 min baseline period and average of the 4 min task period

Awards & highlights

CHARM Trial Summary

This trial examines how brief psychological challenges affect heart rate, blood pressure, and other signs of cardiovascular health among adult volunteers.

Who is the study for?

This trial is for adults who can visit the University of Pittsburgh twice, speak English, and have stable blood pressure. It's not for those with certain neurological disorders, recent major heart issues or surgeries, current pregnancy or childbirth within six months, use of specific medications like anticonvulsants or glucocorticoids, severe lung/liver/kidney diseases including cancer treatment in the past year (except non-melanoma skin cancer), mental health conditions like bipolar disorder or schizophrenia, discomfort with math tasks or MRI tests, sleep apnea diagnosis, and those with MRI-unsafe implants.Check my eligibility

What is being tested?

The study investigates how adult volunteers' cardiovascular systems respond to a psychological challenge. Participants will provide health information and undergo body composition assessments along with monitoring of blood pressure and heart rate. They'll also perform a challenging psychological task while their cardiovascular activity is measured. Additionally, they'll have an MRI scan and complete cognitive tests to explore links between cardiovascular responses to stressors and overall cerebrovascular health.See study design

What are the potential side effects?

Since this trial involves non-invasive procedures such as questionnaires, interviews, standard medical measurements (like blood pressure), a mathematical task under time constraints which might cause temporary stress or anxiety during participation; there are no significant physical side effects expected from participating in this study.

CHARM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ mean sbps for the computation of change scores will be computed from the average of the 5 min baseline period and average of the 4 min task period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~mean sbps for the computation of change scores will be computed from the average of the 5 min baseline period and average of the 4 min task period

This trial's timeline: 3 weeks for screening, Varies for treatment, and mean sbps for the computation of change scores will be computed from the average of the 5 min baseline period and average of the 4 min task period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in systolic blood pressure (SBP) from baseline to task

Endothelial function

Hippocampal volume

+4 more

CHARM Trial Design

1Treatment groups

Experimental Treatment

Group I: Paced Auditory Serial Addition TaskExperimental Treatment1 Intervention

For the Paced Auditory Serial Addition Task, volunteers are presented with single digit numbers (1-9), and are instructed to add any given number to the previously presented number, and call out the answer. Volunteers are told that their performance is being monitored by research assistants. Volunteers are provided with a signaling device that they can use to discontinue testing. Lastly, participants will be asked to complete brief questionnaires to assess their levels of experienced threat, challenge, valence, arousal, and sense of control.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,722 Previous Clinical Trials

16,342,496 Total Patients Enrolled

27 Trials studying Stroke

2,704 Patients Enrolled for Stroke

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,838 Previous Clinical Trials

47,851,204 Total Patients Enrolled

86 Trials studying Stroke

537,505 Patients Enrolled for Stroke

Peter J Gianaros, PhDPrincipal InvestigatorUniversity of Pittsburgh

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any restrictions on who may participate in this research endeavor?

"The enrollment criteria for this experiment requires that applicants have experienced a stroke and are within the ages of 40-59. This trial is hoping to accommodate 450 participants."

Answered by AI

Does this research project accept participants who have surpassed the age of 35?

"This particular trial is seeking patients between the ages of 40 and 59, with a total of 49 trials for minors and 501 studies for seniors."

Answered by AI

Are there any open enrollment options for this experiment?

"Based on the information posted to clinicaltrials.gov, this medical trial's recruitment period has ended. It was first published on September 18th 2023 and most recently updated August 31st 2023. Nevertheless, there are 576 other trials actively recruiting patients at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cerebrovascular Health and Resilience in Midlife

Peter Gianaros 2023. "Cerebrovascular Health and Resilience in Midlife". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06029348.