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80 Participants Needed

Cardiometabolic Function Testing for Healthy Adults
(CAMERA Trial)

Overseen ByBarry 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 GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the heart and blood vessels function at rest and during exercise in healthy individuals. Participants will undergo tests such as MRI scans, Dual X-ray absorptiometry (DEXA) scans, and heart function tests to gather data. The study seeks healthy volunteers without a history of heart issues and who do not experience breathlessness or fatigue during daily activities. Volunteers should be comfortable with various testing methods, including some that are more involved. As an unphased trial, this study offers a unique opportunity to contribute to the scientific understanding of cardiovascular health.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that the DEXA scan has no specific conditions making it unsafe. However, it involves a small amount of radiation, which can slightly increase the risk of cancer later in life.

Research shows that MRI scans are generally safe, but patients must undergo a thorough safety check before the scan to ensure no risks, such as metal implants, are present.

Studies have shown that right heart catheterization, which measures heart function, has low complication rates. It is considered safe when performed with proper techniques, such as using ultrasound for guidance.

Overall, these procedures are well-tolerated and carry minimal risks, especially under careful supervision.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial?

Researchers are excited about this trial because it uses advanced imaging techniques to explore cardiometabolic function in healthy adults, which is quite different from traditional methods focused on diagnosing existing conditions. Unlike standard tests that may only offer a snapshot of heart health, the combination of DEXA scans, MRIs, and right heart catheterization provides a comprehensive view of the heart's structure, function, and metabolism. This trial could uncover new insights into how a healthy heart operates, potentially leading to better prevention strategies for heart disease.

What evidence suggests that this trial's treatments could be effective for evaluating cardiometabolic function?

In this trial, healthy volunteers will undergo a DEXA scan, MRI, and Right Heart Catheterization with Hemodynamics and Limited Echocardiogram. Research has shown that DEXA scans effectively measure body composition, providing quick images with low radiation to gather important information about bone strength and body fat. MRI serves as a powerful tool for exploring the connection between the heart and energy use in the body, offering detailed pictures of the heart's structure and function. Right heart catheterization measures heart pressures and blood flow, providing crucial insights into heart function. Together, these methods offer a comprehensive view of heart and metabolic health, aiding doctors in understanding how a healthy heart should function.³ ⁶ ⁷ ⁸ ⁹

Who Is on the Research Team?

Barry A. Borlaug, M.D. - Doctors and ...

Barry Borlaug, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

See 2 more

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.

See 10 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

1Treatment groups

Experimental Treatment

Group I: Healthy VolunteersExperimental Treatment3 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

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]

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 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]

Citations

1.ncbi.nlm.nih.govncbi.nlm.nih.gov/books/NBK519042/

Dual-Energy X-Ray Absorptiometry - StatPearls - NCBI - NIHDual-energy x-ray absorptiometry is comparatively inexpensive, with notably shorter scan times and lower radiation exposure compared to other imaging options. A ...

2.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC7378094/

Body composition with dual energy X-ray absorptiometryIn this review we will explain the technical working principles of body composition with DXA, together with the possible limitations and pitfalls that should ...

3.sciencedirect.comsciencedirect.com/science/article/pii/S0261561425000366

Dual-energy x-ray absorptiometry derived body ...This study aimed to a) establish age- and sex-specific reference values and cut-points for a range of dual-energy x-ray absorptiometry (DXA) derived metrics.

4.link.springer.comlink.springer.com/article/10.1007/s00259-024-06912-6

Updated practice guideline for dual-energy X-ray ...Our aim in this report is to identify key elements pertaining to the use of DXA in clinical practice, considering both technical and clinical aspects.

5.nature.comnature.com/articles/s41598-024-74185-y

Steps to developing a DXA-based risk score for ...Our study aims to develop a body composition-based risk score and integrate it into the Framingham Risk Score (FRS) to improve CVD prediction among well- ...

6.cdc.govcdc.gov/radiation-health/data-research/facts-stats/dexa-scan.html

Facts About Bone Density (DEXA Scan)However, added exposures can slightly increase the risk of developing cancer later in life. What you should know. Your healthcare provider may ...

7.radiologyinfo.orgradiologyinfo.org/en/info/dexa

Bone Density Scan (DEXA or DXA)Risks · There is always a slight chance of cancer from excessive exposure to radiation. · Women should always tell their doctor and x-ray technologist if they are ...

8.iaea.orgiaea.org/resources/rpop/health-professionals/other-specialities-and-imaging-modalities/dxa-bone-mineral-densitometry/patients

Radiation protection of patients during DXAThe typical patient effective dose from a dual energy QCT examination is 50 - 100 μSv. Dose from dual energy QCT is higher than the effective dose from DXA ...

9.sciencedirect.comsciencedirect.com/science/article/pii/S1094695006603314

Precision Assessment and Radiation Safety for Dual ...It is recommended that every DXA technologist conduct a precision assessment and calculate the LSC for each measurement site and DXA instrument used.

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