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PET Scans for Heart Disease Risk Assessment in Women (HER-CROWN Trial)

Q: How many participants are being accepted into this clinical trial?

<p>Affirmative. The information posted on clinicaltrials.gov indicates that this medical research, which was originally launched on April 26th 2023, is actively recruiting participants. 210 patients must be recruited from 1 institution to complete the trial.</p>

N/A

Recruiting

Led By Kerri-Anne Mullen, PhD

Research Sponsored by Ottawa Heart Institute Research Corporation

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 18 months

Awards & highlights

HER-CROWN Trial Summary

This trial will study the effects of female-specific risk factors on heart disease in women from diverse backgrounds in Canada. It will create a new risk score to predict hard cardiovascular outcomes.

Who is the study for?

This trial is for women in Ontario with a valid health card, aged 25-55, who have specific conditions like gestational diabetes, PCOS, early menopause or inflammatory disorders such as Lupus. It's also open to those who've had pre-eclampsia or breast cancer.Check my eligibility

What is being tested?

The HER CROWN study is testing a new way to predict heart disease in women using their medical history and PET scans. The goal is to create a risk score that considers female-specific factors and represents Canada's ethnic diversity.See study design

What are the potential side effects?

Since the intervention involves PET scans, potential side effects may include discomfort at the injection site for the tracer used in the scan and exposure to low levels of radiation.

HER-CROWN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 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

Arterial tonometry

Blood work

Cardiac PET

+15 more

HER-CROWN Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sex-Specific Risk HDP Subgroup Factor Group and Age-Matched Control GroupExperimental Treatment1 Intervention

Blood sample Questionnaires Arterial stiffness assessment Transthoracic Echocardiogram Coronary Computed Tomography Angiography (CTA) Cardiac Positron Emission Tomography (PET)

Group II: Sex-Specific Risk factor group and Age-Matched Control GroupActive Control1 Intervention

Blood sample Questionnaires Arterial stiffness assessment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PET scan

2016

Completed Phase 2

~650

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor

188 Previous Clinical Trials

92,226 Total Patients Enrolled

Kerri-Anne Mullen, PhDPrincipal InvestigatorUOHI

1 Previous Clinical Trials

1,208 Total Patients Enrolled

Media Library

Sex-Specific Risk HDP Subgroup Factor Group and Age-Matched Control Group Clinical Trial Eligibility Overview. Trial Name: NCT05632601 — N/A

Cardiovascular Disease Research Study Groups: Sex-Specific Risk HDP Subgroup Factor Group and Age-Matched Control Group, Sex-Specific Risk factor group and Age-Matched Control Group

Cardiovascular Disease Clinical Trial 2023: Sex-Specific Risk HDP Subgroup Factor Group and Age-Matched Control Group Highlights & Side Effects. Trial Name: NCT05632601 — N/A

Sex-Specific Risk HDP Subgroup Factor Group and Age-Matched Control Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05632601 — N/A

Frequently Asked Questions

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

Is there still room available to join this clinical trial?

"Confirmed. According to the data posted on clinicaltrials.gov this trial, which was first released April 26th 2023 and recently modified May 8th of that same year, is actively recruiting 210 individuals from a single medical site."

Answered by AI

Is there an age limit to partaking in this research?

"Patients age 25 to 55 may partake in this trial; however, anyone younger than 18 or older than 65 should look into the 30 and 384 studies dedicated to those age brackets."

Answered by AI

Is there an opportunity to become a participant in this clinical research?

"This scientific investigation is enlisting 210 individuals with cardiovascular disease aged between 25 and 55 years. Notably, applicants should fulfill the following prerequisites: Premature menopause (menopause < 40 yrs.), Early onset of menopausal symptoms (40-45), Polycystic ovarian syndrome (PCOS), Rheumatoid/Psoriatic arthritis & Lupus, Breast cancer history, Female gender identity, Between 25-55 in age bracket, Ontario residency with valid OHIP coverage, Pre-eclampsia/Eclampsia or Gestational hypertension risks, Gestational diabetes diagnosis."

Answered by AI

How many participants are being accepted into this clinical trial?

"Affirmative. The information posted on clinicaltrials.gov indicates that this medical research, which was originally launched on April 26th 2023, is actively recruiting participants. 210 patients must be recruited from 1 institution to complete the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reexamining Her Cardiovascular Risk - Ottawa WomeN's Longitudinal Cohort Study

2023. "Reexamining Her Cardiovascular Risk - Ottawa WomeN's Longitudinal Cohort Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05632601.

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