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PACESETTER for High Blood Pressure

N/A

Waitlist Available

Research Sponsored by Northern California Institute of Research and Education

Eligibility Criteria Checklist

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

Must have

Able to take their own BP and self-administer medications

history of stroke (within six months of symptom onset)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial aims to assess the feasibility of a stroke intervention in two US health systems. If successful, the intervention could be exported to other medically underserved populations in the US.

Who is the study for?

The PACESETTER trial is for African American or non-Hispanic white individuals who have had a stroke within the last six months and suffer from uncontrolled high blood pressure. Participants must be able to measure their own blood pressure, take medications without assistance, and own a smartphone with a data plan. It's not suitable for those with severe cognitive impairments, major disabilities, extreme obesity (BMI > 40), or language barriers in English.Check my eligibility

What is being tested?

PACESETTER is testing an intervention designed to prevent strokes by using electronic tracking and personalized management of high blood pressure in low-resource settings. The program will be integrated into health systems in areas heavily affected by strokes to see if it can effectively manage post-stroke care among underserved populations.See study design

What are the potential side effects?

Since PACESETTER involves monitoring and managing high blood pressure rather than medication or invasive procedures, direct side effects are minimal. However, participants may experience stress or anxiety related to consistent health tracking and potential lifestyle changes required.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take my blood pressure and manage my medications by myself.

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I had a stroke less than 6 months ago.

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I had a stroke less than 6 months ago.

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I can take my blood pressure and manage my medications by myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Systolic BP

Secondary outcome measures

Longitudinal Comparisons of BP

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PACESETTERExperimental Treatment1 Intervention

Group II: Healthy Lifestyle Intervention GroupActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PACESETTER

2020

N/A

~120

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of South CarolinaOTHER

211 Previous Clinical Trials

120,339 Total Patients Enrolled

Medical University of South CarolinaOTHER

932 Previous Clinical Trials

7,394,140 Total Patients Enrolled

Regional Medical Center: Orangeburg HospitalUNKNOWN

Media Library

PACESETTER Clinical Trial Eligibility Overview. Trial Name: NCT03401489 — N/A

High Blood Pressure Research Study Groups: Healthy Lifestyle Intervention Group, PACESETTER

High Blood Pressure Clinical Trial 2023: PACESETTER Highlights & Side Effects. Trial Name: NCT03401489 — N/A

PACESETTER 2023 Treatment Timeline for Medical Study. Trial Name: NCT03401489 — N/A

Frequently Asked Questions

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

How many participants can join this clinical research project?

"Absolutely. According to clinicaltrials.gov, this analysis has been open for enrollment since July 14th 2020 and is still recruiting participants now - the most recent update was on September 29th 2022. 200 patients are required from 4 distinct sites in total."

Answered by AI

Does the age restriction of this trial preclude those under 65 from participating?

"To take part in this clinical trial, patients must be aged between 18 and 80. In contrast, there are 58 trials for minors below the age of consent and 718 for those over 65 years old."

Answered by AI

To whom is this clinical research open?

"For this clinical trial, physicians are looking to enroll 200 people who have hypertension. These participants must range in age from 18 to 80 and be either African American or non-Hispanic white. Additionally they should have experienced a stroke within the last six months before recruitment as well as uncontrolled high blood pressure (SBP ≥ 130 mmHg). They will also need to own a smartphone with an active data plan for monitoring purposes, plus possess the ability to both take their own BP readings and self-administer medications."

Answered by AI

Are there many sites in North America where this research is occurring?

"Presently, this clinical trial is recruiting from 4 different medical locations: University of South carolina in Columbia, Medical University of South Carolina in Charleston, and NCIRE in San Francisco; as well as an additional four sites."

Answered by AI

Is enrollment for the trial still available?

"The clinical trial is still actively recruiting, as per the latest update on clinicaltrials.gov which notes its initial posting date of July 14th 2020 and final modification on September 29th 2022."

Answered by AI