210 Participants Needed

PET Scans for Heart Disease Risk Assessment in Women

(HER-CROWN Trial)

KM
CV
Overseen ByCarolyn Van Dam
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Ottawa Heart Institute Research Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment PET scan for heart disease risk assessment in women?

PET scans are shown to be a powerful tool for diagnosing and assessing the risk of heart disease in women, offering improved accuracy even in challenging cases and lower radiation exposure. They help in diagnosing heart issues early, which can lead to better treatment and management of heart disease in women.12345

Is PET imaging safe for women?

PET imaging is generally considered safe for women, but there are concerns about radiation exposure. Techniques to reduce radiation are recommended to minimize any potential risks.26789

How does PET imaging differ from other treatments for assessing heart disease risk in women?

PET imaging for heart disease risk assessment in women is unique because it offers improved diagnostic accuracy, even in the presence of breast tissue or small heart size, and uses short-lived radiopharmaceuticals to reduce radiation exposure. It also allows for the quantification of blood flow to diagnose heart issues, even when there are no obvious blockages in the arteries.24101112

What is the purpose of this trial?

The full HER CROWN will be a prospective cohort study to propose a novel, women-specific cardiovascular risk score/ algorithm in the prediction of hard cardiovascular outcomes (myocardial infarction, unstable angina, coronary revascularization, stroke, total and cardiovascular mortality). This future study will be the first longitudinal cohort study, to our knowledge, that is focused entirely on researching the pathophysiology and natural history of cardiovascular disease in women with known female-specific risk factors. Further, the investigators are aiming to recruit a sample that is representative of the ethnic distribution in Canada. The proposed pilot study is a feasibility study as an essential preparatory step for HER CROWN.

Research Team

KM

Kerri-Anne Mullen, PhD

Principal Investigator

UOHI

Eligibility Criteria

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.

Inclusion Criteria

I am between 25 and 55 years old.
I am female.
Ontario resident with a valid OHIP card
See 1 more

Exclusion Criteria

Untreated serious mental illness (e.g., untreated psychosis)
I am male.
Currently pregnant
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vanguard Phase

Feasibility study to evaluate the full study being planned, including blood samples, questionnaires, and various cardiovascular assessments

18 months
Multiple visits for assessments and data collection

Follow-up

Participants are monitored for safety and effectiveness after the vanguard phase

6 months

Treatment Details

Interventions

  • PET scan
Trial Overview 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials
200
Recruited
95,800+

Findings from Research

Women experience higher complication rates and in-hospital mortality after myocardial infarction compared to men, despite having a smaller overall burden of coronary artery disease (CAD).
Certain risk factors, such as diabetes, low HDL cholesterol, high triglycerides, and psychological depression, are particularly concerning for women and can lead to worse outcomes in CAD.
Cardiovascular disease in women: sex differences in presentation, risk factors, and evaluation.Polk, DM., Naqvi, TZ.[2022]
In a study of 619 patients (138 women) followed for an average of 5.7 years, abnormal myocardial perfusion identified by PET was linked to a significantly higher risk of adverse cardiovascular events in women compared to men, indicating a need for gender-specific risk assessment.
While abnormal coronary flow reserve (CFR) was a strong predictor of long-term cardiac events in men, it did not show the same predictive value in women, suggesting that current imaging strategies may need to be refined for better risk prediction in female patients.
Sex differences in the long-term prognostic value of 13N-ammonia myocardial perfusion positron emission tomography.Gebhard, C., Fiechter, M., Herzog, BA., et al.[2018]
Mortality from coronary artery disease in women decreased from nearly 500,000 in 2000 to 398,096 in 2013, indicating progress but still highlighting the need for improved awareness and management of cardiovascular diseases.
Advancements in cardiovascular imaging have enhanced the early diagnosis and management of ischemic heart disease, suggesting that personalized applications of these technologies could lead to further reductions in mortality among women.
Changing the trajectory of ischemic heart disease in women: Role of imaging.Dorbala, S., Shaw, LJ.[2021]

References

Cardiovascular disease in women: sex differences in presentation, risk factors, and evaluation. [2022]
Sex differences in the long-term prognostic value of 13N-ammonia myocardial perfusion positron emission tomography. [2018]
Changing the trajectory of ischemic heart disease in women: Role of imaging. [2021]
The role of positron emission tomography in the evaluation of myocardial ischemia in women. [2018]
Coronary artery disease. The other half of the heaven. [2016]
Relation between pharmacological stress ECG, 13NH3-PET/CT outcome and the occurrence of cardiac events during follow-up in women with chest pain. [2021]
Myocardial perfusion imaging in women for the evaluation of stable ischemic heart disease-state-of-the-evidence and clinical recommendations. [2023]
Coronary microvascular dysfunction in women with nonobstructive ischemic heart disease as assessed by positron emission tomography. [2020]
Cardiac CT in women: clinical application and considerations. [2016]
10.United Statespubmed.ncbi.nlm.nih.gov
Gender-related imaging issues in assessment of coronary artery disease by nuclear techniques. [2018]
Update on myocardial blood flow quantification by positron emission tomography. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Detection of coronary artery disease in women. The pitfalls of noninvasive tests. [2016]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity