Coronary Artery Calcification

13

Review clinical trials related to Coronary Artery Calcification. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Tissue Validation of Mammographic Breast Arterial Calcification in Mastectomy Specimens (SIDEMARA)

Breast arterial calcification (BAC) is a common incidental finding on screening mammograms and has been associated with cardiovascular disease in women. However, every study in this field has been imaging-based. The accuracy of mammography for detecting breast arterial calcification has only ever been measured against another radiologist reading the same mammogram, never against the tissue itself. As a result, it is not known how much calcification mammography misses, nor whether what it shows represents medial (Monckeberg-type) calcification or true atherosclerosis. This prospective observational study compares mammographic BAC with the histopathology of breast arteries obtained from mastectomy specimens. Women aged 40 years and older undergoing upfront mastectomy, without neoadjuvant therapy, for invasive breast cancer or ductal carcinoma in situ will be enrolled consecutively. Additional tissue blocks will be taken from tumour-free areas of the specimen and examined with von Kossa and elastic van Gieson stains to determine whether arterial calcification is present and whether it lies in the media or the intima. These findings will be compared with the preoperative mammogram, which is read independently and blind to the pathology result. As a secondary and exploratory objective, coronary artery calcification will be scored from staging computed tomography images already acquired for cancer staging. No additional tests, imaging, radiation exposure or blood sampling will be performed for the purposes of this study, and the surgical procedure will not be altered in any way.

Participants needed: 100
Trial details
Age: 40+Biological sex: FemaleType: ObservationalSponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUpdated: Oct 8, 2026
Eligibility criteria

Female [+4]

Neoadjuvant chemotherapy or neoadjuvant endocrine therapy [+9]

Status: Recruiting

Cardiovascular Risk Assessment and Coronary Calcium Score in Thai MASLD Patients

Metabolic dysfunction-associated steatotic liver disease (MASLD) is common in Thailand and is strongly linked to metabolic risk factors such as obesity, diabetes, hypertension, and dyslipidemia. Cardiovascular disease is the leading cause of death among patients with MASLD. Coronary artery calcium (CAC) scoring is a widely used marker of subclinical coronary atherosclerosis. This study aims to evaluate the association between cardiovascular risk assessment tools and CAC scores in Thai patients with MASLD to improve cardiovascular risk stratification in this population.

Participants needed: 251
Trial details
Age: 35-75Biological sex: AllType: ObservationalSponsor: Watcharasak ChotiyaputtaUpdated: Oct 8, 2026Locations: 1Duration: 10 Years
Eligibility criteria

Asymptomatic [+3]

History of myocardial infarction, PCI, or CABG [+8]

Status: Not yet recruiting

Artificial Intelligence - Based Opportunistic Coronary Artery Calcium Scoring on Routine Chest-CT Scan

This retrospective, non-interventional study externally validates a pre-trained open-weight deep-learning algorithm (Swin-UNETR) for the opportunistic quantification of coronary artery calcium (CAC) on non-gated routine chest CT scans acquired at a German academic center, and evaluates the prognostic value of this automated imaging biomarker for cardiovascular risk stratification. Coronary calcium is an established predictor of cardiovascular risk, but is not routinely quantified on the tens of thousands of non-cardiac chest CTs performed each year. Because existing high-performing AI models were trained almost exclusively on U.S. cohorts, external validation on a European scanner fleet is required to exclude scanner bias (domain shift). The study comprises three linked analytic cohorts: (1) a validation cohort comparing the AI-CAC score against the ECG-gated cardiac CT Agatston reference; (2) a dialysis cohort assessing calcification progression and mortality; and (3) an emergency department cohort assessing short-term cardiovascular events. This is an investigator-initiated trial with no intervention on patients.

Participants needed: 1,950
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University of CologneUpdated: Sep 9, 2026
Eligibility criteria

Validation cohort: patients with a paired non-gated chest CT and an ECG-gated ca... [+2]

Documented objection to the scientific use of the data pursuant to Art. 21 GDPR. [+1]

Status: Not yet recruiting

Health Enhanced Artery Risk Tracking With Widespread Implementation and Screening Effort in ASCVD (HEARTWISE-ASCVD)

This multi-site study will test whether an opportunistic AI-based CAC screening and notification intervention can improve cholesterol treatment and lower cholesterol levels in adults. The study uses artificial intelligence to detect calcium buildup in heart arteries (coronary artery calcium or CAC) on chest CT scans that patients have already had for other reasons. The study will focus on adults who either have known atherosclerotic cardiovascular disease (ASCVD) or have significant calcium buildup (a CAC score of 100 or higher), and whose cholesterol is not well controlled. It will also evaluate how well this approach can be implemented at scale across multiple health systems. The main questions it aims to answer are: Does notifying patients and their clinicians about incidental CAC increase lipid-lowering therapy(LLT) initiation or intensification? Does the intervention improve Low-Density Lipoprotein(LDL)-cholesterol control and related lipid testing? How does the intervention affect downstream care (e.g., clinic visits, cardiology referrals, and cardiac testing)? Researchers will use an FDA-cleared AI algorithm to quantify CAC on previously performed non-gated chest CT scans and identify eligible participants through the electronic health record. Participants will be randomized to receive CAC notification either right away or after a 6-month delay.

Participants needed: 120,000
Trial details
Age: 18-74Biological sex: AllType: InterventionalSponsor: Stanford UniversityUpdated: Apr 22, 2026Locations: 6
Eligibility criteria

Non-gated chest CT performed within the prior 2 years within the health system [+6]

Dementia [+4]

Status: Not yet recruiting

Lithotripsy Versus Balloon Angioplasty for Optimal Treatment of CAlcified Lesions With and Without Optical Coherence Tomography evaluatION

Severely calcified coronary artery disease means that calcium has built up in the blood vessels that supply the heart. This makes coronary procedures more difficult and increases the risk of complications during and after treatment. The LOCATION Study is a large clinical study designed to compare different commonly used treatment strategies for patients with severely calcified coronary arteries who need a coronary stent. The study aims to find safer and more effective ways to prepare the artery and place the stent in order to improve long-term outcomes. In this study, participants will be randomly assigned (like flipping a coin) to one of four treatment groups during their coronary procedure. The treatments differ in two ways: (1) how the calcified artery is prepared before placing the stent, and (2) how imaging is used to guide stent placement. One method uses a shockwave-based device to help break calcium in the artery, while the other uses standard balloon treatment. For imaging guidance, one approach uses a high-resolution imaging catheter inside the artery, and the other relies on standard X-ray imaging. All participants will receive a standard, approved drug-eluting stent as part of routine care. The main goal of the study is to determine which treatment approach best reduces serious heart-related problems over three years. These problems include heart-related death, heart attack in the treated vessel, or the need for another procedure on the same vessel. Adults aged 18 years or older with significant coronary artery narrowing and severe calcium buildup may be eligible to participate. All participants must provide written informed consent before joining the study. Participants will be followed during their hospital stay and through regular follow-up visits or phone calls for up to three years after the procedure. Information collected during the study will help doctors better understand how to treat patients with severely calcified coronary arteries in the future. Participation in this study is voluntary, and patients may withdraw at any time without affecting their medical care. All study devices used in this trial are approved for clinical use, and patient privacy will be protected according to applicable regulations.

Participants needed: 3,060
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Shanghai Bluesail Boyuan Medical Technology Co., Ltd.Updated: Mar 12, 2026Locations: 1
Eligibility criteria

Age ≥18 years; [+10]

Clinical exclusion criteria: [+18]

Status: Not yet recruiting

Intravascular Imaging-Guided Intravascular Lithotripsy for Severe Coronary Calcified Lesions.

This study aims to investigate the efficacy and safety of intravascular lithotripsy (IVL) balloon in treating coronary calcified lesions at our center.

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: The First Affiliated Hospital with Nanjing Medical UniversityUpdated: Mar 2, 2026Locations: 1Duration: 6 Months
Eligibility criteria

Patients with coronary angiography showing vessel diameter stenosis ≥ 70% and mo... [+2]

Patients with comorbid conditions such as malignant tumors and an expected lifes... [+3]

Status: Recruiting

A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries

This study is a single-center, prospective, controlled, diagnostic study. The study will be consecutive and is expected to enroll 100 patients with CCTA confirmed coronary calcified lesions. The purpose of this study was to compare the accuracy of novel Ferumoxytol-enhanced Cardiac Magnetic Resonance (Fe-CMR) and coronary CT angiography (CCTA) in detecting calcified coronary arteries, using coronary angiography (CAG) and optical coherence imaging (OCT) as gold standards.

Participants needed: 100
Trial details
Age: 18-75Biological sex: AllType: ObservationalSponsor: The First Affiliated Hospital with Nanjing Medical UniversityUpdated: Feb 10, 2026Locations: 1
Eligibility criteria

Age ≥18 years, <75 years; [+4]

People who are allergic to iodine contrast media or have a history of allergy to... [+11]

Status: Recruiting

High-intensity Statin and Ezetimibe Therapy for Asymptomatic Patients With Positive Coronary Calcium

The aim of this study is to compare safety and efficacy between the aggressive treatment with combination of high-intensity statin and ezetimibe and the current standard lipid lowering treatment in asymptomatic patients with presence of coronary calcification.

Participants needed: 6,000
Trial details
Phase: Phase 4Age: 40+Biological sex: AllType: InterventionalSponsor: Samsung Medical CenterUpdated: Jan 14, 2025Locations: 1
Eligibility criteria

Subject must be at least 40 years of age. [+2]

Objective evidence of at least moderate inducible ischemia requiring revasculari... [+9]

Status: Recruiting

COMPLEX Registry - a Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting with CompLEX and Calcified Coronary Artery Disease

The purpose of the COMPLEX Registry is to prospectively and retrospectively collect baseline, clinical and procedural data of patients who have undergone PCI or CABG for complex and/ or calcified chronic CAD, irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. The outcomes will be compared in different clinical subgroups (e.g. PCI vs. CABG). The impact of current PCI techniques/ devices, but also CABG strategies in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.

Participants needed: 5,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Luzerner KantonsspitalUpdated: Oct 29, 2024Locations: 1Duration: 10 Years
Eligibility criteria

Subject >18 years of age [+9]

Patient is <18 years of age [+2]

Status: Recruiting

SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With SIROlimus Or Paclitaxel Eluting Balloon Catheters

The purpose of the SIROOP Registry is to retrospectively and prospectively collect baseline, clinical and procedural characteristics of patients who have undergone PCI and are treated with either currently available sirolimus or paclitaxel coated DCBs (see Table 1), irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. Outcomes will be compared in different clinical subgroups. The impact of current DCBs in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.

Participants needed: 2,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Luzerner KantonsspitalUpdated: Oct 29, 2024Locations: 1Duration: 10 Years
Eligibility criteria

Subject >18 years of age [+3]

Patient is <18 years of age [+3]

Status: Recruiting

The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial

Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation has become the dominant treatment strategy for patients with acute and chronic coronary artery disease (CAD) requiring revascularization. Nonetheless, PCI with stent implantation has some limitations and especially patients with severely calcified coronary lesions (approximately 10-20% of all patients with CAD) have an elevated risk for adverse outcomes, including target lesion failure (TLF) and stent thrombosis (ST). Several dedicated PCI devices have been developed for treatment of severely calcified lesions. Whereas especially two of them have shown promising results in smaller, prospective studies. First, the super high-pressure NC PCI balloon (OPN™ NC, SIS Medical AG, Frauenfeld, Switzerland) has been shown to represent an effective and safe device for lesion preparation. Second, the lately introduced Shockwave intravascular lithotripsy (IVL)™ balloon catheter (Shockwave Medical, Santa Clara, CA, USA) appears to be a safe and efficient alternative device for treatment of calcified coronary lesions. However, it remains unknown, if the OPN™ NC balloon is non-inferior to to IVL regarding lesion preparation and completeness of stent expansion in severely calcified lesions.

Participants needed: 280
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Luzerner KantonsspitalUpdated: Jun 18, 2024Locations: 1
Eligibility criteria

Age ≥18 years and consentable; [+12]

Patient experienced an acute STEMI or cardiogenic shock related to an acute MI w... [+17]

Status: Recruiting

Coronary Artery Calcification in Type 2 Diabetes Mellitus (USCAC Study)

Coronary artery calcification (CAC) is a common complication of type 2 diabetes mellitus(T2DM), which can significantly increase all-cause mortality and the incidence of serious cardiovascular events, and increase the burden of the national economy. The epidemiological characteristics and the clinical progress of CAC are still not clear. Moreover, the pathogenesis of CAC has not yet been fully elucidated, and lack of specific diagnostic indicators. Arterial calcification is an active, reversible, and multifactorial biological process like bone formation. It is generally believed that early detection of calcification lesions and active targeted treatment may be the key to prevention and treatment of vascular calcification. In addition, statins are commonly used in patients with dyslipidemia and can stabilize CAC plaque. However, the timing, dosage and effect of statins are controversial. Moreover, our previous study found that the expression of miR-32 is significantly elevated in patients with CAC, and can promoting vascular calcification. Herein, this study is to conduct a prospective cohort study on T2DM patients with CAC in Hunan province through a multidisciplinary and multi-center cooperation model, the main research objectives include the following three parts: ① To identify the prevalence, incidence, and characteristics of CAC in T2DM patients in Hunan province, and to build a risk assessment model. ② To observe the effects of statins on the occurrence and development of CAC in patients with T2DM, and to provide clinical data for the improvement of medication guidelines; ③To observe the dynamic changes of serum miR-32 in the progression of CAC in patients with T2DM, and to explore its possibility as a serological diagnosis or prognostic bio-maker of CAC. The completion of this research project is expected to bring a new breakthrough in the field of early diagnosis, prognosis evaluation, and intervention treatment of patients with T2DM combined with CAC, and provide an important reference for the formulation of cardiovascular disease prevention and control strategy.

Participants needed: 1,400
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University of South ChinaUpdated: Sep 29, 2021Locations: 1
Eligibility criteria

Age ≥ 18 years old [+3]

Those have received coronary artery stenting or coronary artery bypass grafting [+7]

Status: Recruiting

ROVUS Asia Registry (Evaluate Safety and Effectiveness of Rotational Atherectomy and Intravascular Ultrasound for Heavily Calcified Coronary Lesion)

Rotablation with or without other calcium debulking therapies is a safe adjunctive procedure for patients with severe coronary calcification requiring Percutaneous Coronary Intervention (PCI).

Participants needed: 1,000
Trial details
Age: 21+Biological sex: AllType: ObservationalSponsor: National Heart Centre SingaporeUpdated: Apr 23, 2021Locations: 2Duration: 1 Year
Eligibility criteria

Able to understand and sign an informed consent form [+9]

Decline to give consent