5000 Participants Needed

Research Pulse Sequences for Heart Disease

Recruiting at 1 trial location
RD
Overseen ByRebecca D Huffstutler, C.R.N.P.
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
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 focuses on individuals with unusual heart or blood vessel issues, often linked to metabolic, inflammatory, or genetic conditions. Researchers aim to understand how these diseases affect the heart and blood vessels by collecting samples and conducting various tests, such as heart imaging and stress tests. The trial includes individuals with known or suspected heart conditions, their relatives, and healthy volunteers. Ideal participants are those with rare heart-related conditions or their family members, as well as healthy adults willing to provide samples for research. As an unphased study, this trial offers participants a unique opportunity to contribute to groundbreaking research that could lead to better understanding and treatment of rare heart conditions.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study researchers to get a clear answer.

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

Research has shown that 11C-Acetate is often used in PET scans to examine tumors. Some individuals might experience stomach issues such as nausea or diarrhea, though these side effects are uncommon.

For 13N-Ammonia, studies indicate it typically does not cause adverse reactions and is frequently used for heart imaging. The primary concern is radiation exposure, so using the smallest necessary amount is crucial for safety.

Overall, both substances are used in medical imaging and have been studied extensively. Most individuals tolerate them well, but, as with any treatment, some risks exist.12345

Why are researchers excited about this trial?

Researchers are excited about the use of 11C-Acetate and 13N-Ammonia in cardiovascular studies because these compounds offer unique insights into heart function. Unlike traditional imaging techniques that primarily observe structural changes, these radiotracers allow for real-time observation of metabolic processes. 11C-Acetate provides detailed information on myocardial oxygen consumption, helping to assess heart efficiency, while 13N-Ammonia is excellent for evaluating blood flow within the heart. This metabolic and perfusion-focused approach could lead to earlier and more accurate diagnoses of uncommon cardiovascular diseases, offering a potential advantage over standard imaging methods.

What evidence suggests that this trial's treatments could be effective for cardiovascular diseases?

This trial will study both 11C-acetate and 13N-ammonia. Research has shown that 11C-acetate can assess heart health by evaluating how well the heart uses oxygen. Efficient oxygen use is crucial for optimal heart function. Studies suggest that acetate might also lower the risk of ischemic heart disease, a condition where blood flow to the heart is reduced.

For 13N-ammonia, studies indicate it can assess blood flow in heart muscles. Good blood flow is essential for a healthy heart. 13N-ammonia has been used to monitor heart conditions and evaluate treatment effectiveness over time. Both tools provide doctors with a clearer understanding of heart health and potential risks.678910

Who Is on the Research Team?

MN

Michael N Sack, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Are You a Good Fit for This Trial?

Inclusion Criteria

Eligible subjects may include anyone over 1 year of age who is affected with diseases/disorders (index cases), or who is a relative of a person who is affected with diseases/disorders. Relatives may include genetic carriers and non-carriers.
Index case subjects enrolled in this protocol will have been referred with a known or suspected pathology that may be associated with cardiovascular dysfunction or risk with a suspected atypical presentation, heritable disorder, or genetic predisposition. The investigator with expertise in the presentation of the subject, along with consulting specialists, will review the medical history and may review any medical records that are available of prospective subjects and offer admission based upon the potential to help the individual, to learn from the subject, or to initiate clinical or basic research suggested by the subject s workup.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Initial Assessment

Participants undergo various tests including photography, body measurements, radiography, metabolic stress testing, echocardiography, MRI, CT angiogram, PET imaging, six-minute walk test, and vascular ultrasound. Blood, tissue, and other specimens are collected.

Follow-up

Participants may undergo follow-up studies under separate research protocols to monitor disease progression and response to any interventions.

What Are the Treatments Tested in This Trial?

Interventions

  • 11C-Acetate
  • 13N-Ammonia

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: 3. Healthy adult volunteersExperimental Treatment0 Interventions
Group II: 2. Child index case and child relativesExperimental Treatment1 Intervention
Group III: 1. Adult index cases and relativesExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials
3,987
Recruited
47,860,000+

Citations

Using Genetics to Assess the Role of Acetate in Ischemic ...

This study indicates that acetate may be associated with a lower risk of ischemic heart disease (IHD), with an odds ratio (OR) of 0.62 per standard deviation ( ...

11C-acetate PET: a powerful tool to analyze metabolic and ...

This analysis of cardiac efficiency has provided valuable perspectives on the energetic basis of heart failure and the mechanisms behind various treatments, ...

Using Genetics to Assess the Role of Acetate in Ischemic ...

Results: This study indicates that acetate may be associated with a lower risk of ischemic heart disease (IHD), with an odds ratio (OR) of 0.62 ...

The Utility of Nuclear Imaging in Hypertrophic ...

The clearance rate of 11C-acetate can be used to reflect myocardial oxygen consumption (MVO2). MVO2 can be used to calculate myocardial external efficiency ...

evaluation of rv function and metabolism in

Acute improvement of cardiac efficiency measured by 11c-acetate pet after cardiac resynchronization therapy and clinical outcome. The international journal ...

PENN UNION CUAL AID #11C

May cause gastrointestinal irritation, nausea, vomiting and diarrhea. Page 6. PENN UNION CUAL AID #11C. Safety Data Sheet.

The Potential of 11C-acetate PET for Monitoring the Fatty Acid ...

11 C-acetate is directly linked to the fatty acid synthesis pathway, this probe provides a unique opportunity to monitor lipogenic tumors by PET.

1-11C-Acetate as a PET Radiopharmaceutical for Imaging ...

1- 11 C-acetate uptake in prostate tumors was confirmed, leading to a possible marker for FAS expression in vivo by noninvasive PET.

• SAFETY DATA SHEET

Copper(II) acetate is harmful if swallowed, causes severe skin burns and eye damage, and is very toxic to aquatic life. It is also a Category 4 ...

Development and Optimization of 11C-Labeled Radiotracers

Our data showed that [11C]HC070 is a TRPC5-specific radiotracer with high brain uptake and good brain washout pharmacokinetics in both rodents ...