Is NCT07232069 recruiting in Hiram, GA?

Yes, NCT07232069 is currently recruiting participants at its Hiram, GA location. This coronary artery disease risk factors multiple clinical trial is actively enrolling qualified participants.

Is participation in this Hiram clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Coronary Artery Disease Risk Factors Multiple Clinical Trial in Hiram, GA

Q: How do I join the coronary artery disease risk factors multiple clinical trial in Hiram?

To join this clinical trial in Hiram, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Coronary Artery Disease Risk Factors Multiple Study in Hiram

Heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States. This clinical trial will test if screening and early treatment of mild heart disease works. PRE-EMPT will screen individuals at low 10-year risk of heart disease with heart disease risk factors to identify those who already have early cholesterol build up, also called "plaque", in their heart arteries. It consists of two phases: 1. A Screening Study - Participants will be assessed for plaque by one or both of these scans. * Coronary Artery Calcium (CAC) Scan: A CT scan that looks for calcium or plaque in heart arteries. * Coronary CT Angiography (CCTA) Scan: A CT scan that uses contrast dye to create detailed 3D pictures of heart arteries to look for plaque. 2. A Treatment Trial (approximately 1,500 participants) - Based on the results of the CCTA, participants may be randomized into a two-year trial to test medications aimed at reducing or stabilizing plaque. Participants will have a 1 in 4 chance of receiving only placebo, and a 3 in 4 chance of receiving at least one active medication. Participants will take two pills once a day-either both active medications, one active and one placebo, or both placebos. * Rosuvastatin 20 mg: a cholesterol-lowering medicine * Colchicine 0.5 mg: a medication that lowers inflammation Everyone in the trial will be given information and advice on heart-healthy diet and lifestyle. Participants will have up to two in-person visits for the screening study, then phone visits for the Treatment Trial at the beginning, 3 months, 12 months and 24 months when they will also have an in-person visit for a CCTA Scan. Participants will have blood drawn using an at-home collection device mailed to their home at the beginning, 3 months, and end of the study.

Sponsor: Duke University

Who Can Participate

Inclusion Criteria

Women aged 40-60 years; Men aged 30-50 years

Willing and able to provide informed consent and comply with study procedures

Smart phone user

Use of highly effective contraception by females with reproductive potential.

CAC score 1-99 in the screening study or entry through the known plaque pathway (with mild CAC or CAC\<100 if known; elevated CAC on baseline CCTA is not

Exclusion Criteria

ary in the known plaque arm)

Diagnostic baseline CCTA with NCPV ≥10 mm3 as assessed by the central core lab Exclusion Criteria:

Clinical diagnosis of ASCVD including coronary artery disease (CAD), peripheral arterial disease (PAD) or cerebrovascular disease (CeVD)

Current symptoms thought to be from CAD

PREVENT ASCVD 10-year risk ≥5% (if known)

Diabetes Mellitus (DM) as defined by any of the following: DM diagnosis in the medical record or HbA1C of 6.5% or greater. (if known)

LDL-C ≥190mg/dL (most recent, if known)

HIV (if known)

Severe liver disease or untreated Hepatitis C infection (if known)

Pregnancy, lactation or intending to become pregnant during the study period of 2 years

eGFR \<45mL/min/1.73m2 (if known)

AST or ALT \>1.5x the upper limit of normal (if known)

BMI\>40kg/m2 or unable to have a CCTA scan for any reason

Allergy to iodinated intravenous contrast or other contraindication to CCTA

Current or previous use of lipid lowering therapy or colchicine

Known allergic reactions or sensitivity to the study intervention(s), including known intolerance or contraindication(s) to statin or colchicine, or long-term use of medications that are contraindicated with colchicine or rosuvastatin.

Systemic cancer undergoing active treatment

PREVENT ASCVD 10-year risk ≥5%

eGFR \<45 ml/min/1.73m2 per baseline labs, (2021 CKD-EPI equation will be used if multiple options are available)

Hemoglobin A1c ≥6.5% per baseline labs

LDL-C ≥190mg/dL per baseline labs

Severe proximal coronary artery stenosis as determined by the central core lab (≥50% left main or ≥70% proximal major coronary artery stenosis)

Known contraindication to follow-up CCTA (e.g., new IV contrast allergy discovered during the baseline CCTA)

Individuals who are excluded based on any of these factors will be notified as to the reason for exclusion and encouraged to follow-up locally to address this medical issue with their treating physician.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Hiram?

Yes, this clinical trial (NCT07232069) has an active research site in Hiram, GA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Coronary Artery Disease Risk Factors Multiple Treatment Options in Hiram, GA

If you're searching for coronary artery disease risk factors multiple treatment options in Hiram, GA, this clinical trial (NCT07232069) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Hiram research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced coronary artery disease risk factors multiple specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all coronary artery disease risk factors multiple clinical trials near you to find additional studies recruiting in your area.

Coronary Artery Disease Risk Factors Multiple Clinical Trial in Hiram, GA

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