Cardiometabolic Function Testing for Healthy Adults

(CAMERA Trial)

Overseen By Barry Borlaug, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Heart failure, Coronary artery disease, Valvular heart disease, Pulmonary hypertension, Anemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate pulmonary capillary wedge pressure (PCWP) and other hemodynamic measurements at rest and during exercise in healthy volunteers across the age spectrum.

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 study team to get a clear answer.

What data supports the effectiveness of the treatment used in the Cardiometabolic Function Testing for Healthy Adults clinical trial?

The research suggests that MRI, particularly phase-contrast MRI, is being explored for its ability to estimate pulmonary artery pressure and vascular resistance, which are important for assessing heart and lung health. This indicates that MRI can be a useful tool in evaluating cardiometabolic functions, even though it is not yet as precise as invasive methods like right heart catheterization. ^{1 2 3 4 5}

Is dual-energy X-ray absorptiometry (DXA) generally safe for humans?

DXA scans are generally safe for humans, but errors in patient positioning and scan interpretation can lead to incorrect results. These errors do not affect safety but may impact the accuracy of the diagnosis. ^{6 7 8 9 10}

How is the treatment in the Cardiometabolic Function Testing trial unique?

This treatment is unique because it combines several advanced imaging techniques like DXA and MRI to assess body fat distribution and heart function, which can provide a comprehensive view of cardiometabolic health. Unlike traditional methods, this approach offers detailed insights into visceral fat and heart function, potentially improving the understanding of cardiometabolic risks. ^{11 12 13 14 15}

Research Team

Barry Borlaug, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

The CAMERA study is for healthy adults who want to help understand heart and blood vessel function. Participants should be willing to undergo various tests like heart catheterization, MRI, and DEXA scans.

Inclusion Criteria

I am healthy, without symptoms like shortness of breath or tiredness from exercise, and I don't have heart failure.

My heart pumps blood well, with an EF of 50% or higher.

I am willing and able to undergo detailed heart and exercise tests, MRI, and other study checks.

Exclusion Criteria

I experience significant shortness of breath or tiredness with daily activities.

I have high blood pressure in the lungs.

I have a heart muscle disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo Right Heart Catheterization with Hemodynamics, Limited Echocardiogram, MRI, and DEXA scan to measure various cardiac and metabolic parameters at rest and during exercise

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after baseline assessments

4 weeks

Treatment Details

Interventions

• Dual X-ray absorptiometry (DEXA) scan
• Magnetic Resonance Imaging (MRI)
• Right Heart Catheterization with Hemodynamics and Limited Echocardiogram

Trial Overview This study is testing how well the heart and blood vessels work in healthy people of different ages by measuring pressures inside the heart at rest and during exercise using specialized procedures.

Participant Groups

Group I: Healthy Volunteers Experimental Treatment 3 Interventions

Healthy volunteers with no history of Heart Failure (HF) will undergo a Right Heart Catheterization with Hemodynamics and Limited Echocardiogram, MRI, and DEXA scan.

Dual X-ray absorptiometry (DEXA) scan is already approved in United States, European Union for the following indications:

Approved in United States as Dual-energy X-ray absorptiometry for:

• Osteoporosis diagnosis
• Osteopenia diagnosis
• Bone mineral density measurement

Approved in European Union as Dual-energy X-ray absorptiometry for:

• Osteoporosis diagnosis
• Osteopenia diagnosis
• Bone mineral density measurement

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

3D rotational angiography (3DRA) provides highly accurate measurements of pulmonary artery (PA) diameters, showing excellent agreement with traditional methods like catheter angiography (CA) and multi-slice computed tomography (MSCT) in a study involving 18 swine models of congenital heart disease.

Phase-contrast magnetic resonance angiography (PC-MRA) was less effective, failing to reliably visualize stents and distal PA vessels, and it overestimated stenosis diameters while underestimating compliant PA diameters, indicating its limitations in accurately assessing complex PA anatomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of pulmonary artery dimensions in swine obtained from catheter angiography, multi-slice computed tomography, 3D-rotational angiography and phase-contrast magnetic resonance angiography. Pewowaruk, R., Mendrisova, K., Larrain, C., et al.[2021]

A study involving 19 patients with chronic thromboembolic pulmonary hypertension demonstrated that high temporal resolution phase-contrast MRI (PC-MRI) can effectively estimate mean pulmonary arterial pressure (mPAP) with a strong correlation to invasive measurements from right heart catheterization.

The study developed a predictive model for mPAP using PC-MRI parameters, achieving a high goodness of fit (0.892), indicating that PC-MRI could serve as a noninvasive alternative for assessing pulmonary hemodynamics in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive assessment of pulmonary hemodynamics in patients with chronic thromboembolic pulmonary hypertension by high temporal resolution phase-contrast MRI: correlation with simultaneous invasive pressure recordings. Kreitner, KF., Wirth, GM., Krummenauer, F., et al.[2016]

In a study of 17 patients, it was found that conventional cross-sectional magnetic resonance angiography (MRA) measurements of peripheral pulmonary artery stenosis (PPAS) showed only moderate agreement with the gold standard X-ray angiography (XRA), particularly in measuring smaller diameters.

However, when MRA images were reformatted to match the angulations used in XRA, the agreement improved significantly, suggesting that MRA can be a valuable tool for planning catheter interventions for PPAS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Planning of catheter interventions for pulmonary artery stenosis: improved measurement agreement with magnetic resonance angiography using identical angulations. Valverde, I., Parish, V., Hussain, T., et al.[2016]

Contrast-enhanced 3D Magnetic Resonance Angiography (MRA) is proving to be a highly effective noninvasive imaging technique for assessing patients with Peripheral Vascular Disease (PVD).

Ongoing advancements in technology are expected to enhance the performance of Gd-enhanced MRA, positioning it as the leading noninvasive imaging method for PVD globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR angiography for assessment of peripheral vascular disease. Goyen, M., Ruehm, SG., Debatin, JF.[2019]

Contrast-enhanced magnetic resonance pulmonary angiography is feasible for detecting major pulmonary artery pathologies in patients with pulmonary vascular disease, as demonstrated in a study of ten individuals using a 1 Tesla MR scanner.

While the technique effectively identifies issues in the main pulmonary artery and its major branches, it struggles to resolve smaller, distal vessel pathologies, limiting its use for conditions like chronic thromboembolic pulmonary hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional contrast-enhanced magnetic resonance pulmonary angiography in the study of pulmonary vascular pathology. Thomas, B., Farto e Abreu, P., Roquette, J., et al.[2016]

A study of 141 patients in Ecuador revealed that common errors in dual-energy X-ray absorptiometry (DXA) scans, such as incorrect patient positioning, occurred in 31.2% of left hip and 22.4% of right hip scans, which can significantly affect the accuracy of bone mineral density measurements.

Despite existing quality standards for DXA, many imaging centers do not implement them, leading to potential misdiagnoses of conditions like osteoporosis and osteopenia, highlighting the need for better training and adherence to protocols among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common errors in dual-energy X-ray absorptiometry scans in imaging centers in Ecuador. Maldonado, G., Intriago, M., Larroude, M., et al.[2020]

Dual-energy X-ray absorptiometry (DXA) is a highly accurate and precise method for measuring bone mineral content and density, with a precision of 99% and less than 1% error, making it a reliable tool for assessing bone health.

DXA is a safe imaging technique due to its low radiation exposure, allowing for routine use in both adults and infants, and is particularly useful in nutritional studies for determining body composition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soft tissue composition and bone mineral status: evaluation by dual-energy X-ray absorptiometry. Lukaski, HC.[2022]

A study of 8012 patients using dual-energy X-ray absorptiometry (DXA) revealed that cross-calibration errors in bone mineral density measurements can significantly affect osteoporosis diagnoses, with a -10% shift potentially increasing diagnoses by 161% and a +10% shift decreasing them by 64.5%.

The research highlights the importance of maintaining cross-calibration quality control in DXA scans, as even small measurement errors (±4%) can lead to substantial misdiagnosis rates, directly impacting patient treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying misdiagnosis rates from cross-calibration biases and precision errors in dual-energy X-ray absorptiometry of the femoral neck. Fahrenholtz, SJ., Long, JR., Whitaker, MD., et al.[2023]

Central dual-energy X-ray absorptiometry (DXA) is the gold standard for diagnosing osteoporosis and monitoring bone mineral density (BMD), but errors in demographic data, patient positioning, and scan analysis can lead to incorrect clinical decisions.

The paper emphasizes the importance of proper positioning and accurate interpretation of DXA scans to avoid common pitfalls that may result in erroneous BMD results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fundamentals and pitfalls of bone densitometry using dual-energy X-ray absorptiometry (DXA). Watts, NB.[2022]

Dual-energy X-ray absorptiometry (DXA) is the preferred method for measuring bone mineral density (BMD), but it is prone to errors, with up to 90% of reports containing at least one mistake.

Common pitfalls in DXA interpretation can lead to incorrect diagnoses and management, highlighting the importance of awareness and understanding of these errors for healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone Mineral Densitometry Reporting: Pearls and Pitfalls. Martineau, P., Morgan, SL., Leslie, WD.[2021]

In a study involving 1,795 elderly participants and 309 children/adolescents, dual-energy x-ray absorptiometry (DXA) was found to overestimate subcutaneous adipose tissue (SAT) and underestimate visceral adipose tissue (VAT) compared to magnetic resonance imaging (MRI).

The correlation between DXA and MRI was stronger for SAT than for VAT, indicating that while DXA is a reliable method for measuring SAT, its accuracy for VAT is less reliable, especially in individuals with low VAT levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous and visceral fat assessment by DXA and MRI in older adults and children. Maskarinec, G., Shvetsov, YB., Wong, MC., et al.[2023]

In a study of 803 healthy postmenopausal women, visceral adipose tissue (VAT) measured by dual-energy X-ray absorptiometry (DXA) was found to be the strongest predictor of cardiometabolic risk factors, such as blood pressure and cholesterol levels.

Body mass index (BMI) and waist circumference were more strongly correlated with VAT than bioelectrical impedance analysis (BIA), suggesting that traditional anthropometric measures are effective tools for estimating VAT and assessing cardiometabolic risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of adiposity evaluated by anthropometric, BIA, and DXA measures with cardiometabolic risk factors in nonobese postmenopausal women: the CoLaus/OsteoLaus cohort. Stamm, E., Marques-Vidal, P., Rodriguez, EG., et al.[2023]

High-quality DXA scans are crucial for accurately diagnosing osteoporosis and monitoring treatment, but technical errors in scan acquisition and analysis can lead to incorrect diagnoses and misinterpretations of bone density changes.

Clinicians are encouraged to review actual scan images and data rather than relying solely on reports, as this can help identify technical issues and ensure appropriate osteoporosis care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE QUALITY OF DXA SCANS AND REPORTS. Licata, AA., Binkley, N., Petak, SM., et al.[2021]

Bone densitometry, particularly dual-energy x-ray absorptiometry (DXA), is a crucial tool for early diagnosis and treatment of osteoporosis as it accurately measures bone mineral density (BMD) with low radiation exposure.

DXA is favored for its ability to quickly assess BMD in key areas like the spine and hip, providing immediate diagnostic data that is essential for effective patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone densitometry. Chun, KJ.[2022]

A study involving 194 adults found that visceral fat measured by dual-energy X-ray absorptiometry (DXA) is significantly associated with important cardiometabolic risk factors, such as HDL cholesterol and triglycerides, indicating its potential as a valuable measurement tool.

The findings suggest that DXA-derived visceral fat measurements can provide predictive value for insulin sensitivity and other cardiometabolic parameters without the need for more invasive imaging techniques like CT or MRI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Visceral Fat Estimated by Dual-Energy X-ray Absorptiometry Independently Predict Cardiometabolic Risks in Adults? Sasai, H., Brychta, RJ., Wood, RP., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of pulmonary artery dimensions in swine obtained from catheter angiography, multi-slice computed tomography, 3D-rotational angiography and phase-contrast magnetic resonance angiography. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Noninvasive assessment of pulmonary hemodynamics in patients with chronic thromboembolic pulmonary hypertension by high temporal resolution phase-contrast MRI: correlation with simultaneous invasive pressure recordings. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Planning of catheter interventions for pulmonary artery stenosis: improved measurement agreement with magnetic resonance angiography using identical angulations. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

MR angiography for assessment of peripheral vascular disease. [2019]

5. Portugal pubmed.ncbi.nlm.nih.gov

Three-dimensional contrast-enhanced magnetic resonance pulmonary angiography in the study of pulmonary vascular pathology. [2016]

6. England pubmed.ncbi.nlm.nih.gov

Common errors in dual-energy X-ray absorptiometry scans in imaging centers in Ecuador. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Soft tissue composition and bone mineral status: evaluation by dual-energy X-ray absorptiometry. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Quantifying misdiagnosis rates from cross-calibration biases and precision errors in dual-energy X-ray absorptiometry of the femoral neck. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Fundamentals and pitfalls of bone densitometry using dual-energy X-ray absorptiometry (DXA). [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Bone Mineral Densitometry Reporting: Pearls and Pitfalls. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Subcutaneous and visceral fat assessment by DXA and MRI in older adults and children. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Association of adiposity evaluated by anthropometric, BIA, and DXA measures with cardiometabolic risk factors in nonobese postmenopausal women: the CoLaus/OsteoLaus cohort. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE QUALITY OF DXA SCANS AND REPORTS. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Bone densitometry. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

Does Visceral Fat Estimated by Dual-Energy X-ray Absorptiometry Independently Predict Cardiometabolic Risks in Adults? [2022]