Clinical trials: Calcified Coronary Artery Disease
Stable Angina, Coronary Artery Disease
CCTA, CACS and ECG Stress Testing in Patients With Suspected CAD: Precision Phenotyping and Financial Evaluation
The "DATASET-PRECISE", a 3-arm parallel randomized study, aims to provide new insights in risk stratification of patients with suspected CAD in the Greek population.
- Conditions
- Stable Angina, Coronary Artery Disease, Atherosclerosis, Coronary Artery Calcification
- Trial name
- DATASET (NCT04424121)
- Testing
- CCTA
- Where
- 3 sites in Greece
- Volunteers
- 900 people
- Sponsor
- Aristotle University Of Thessaloniki
Coronary Calcification
Effects of Fhytomenadione on Coronary Artery Calcification of Hemodialysis Patients
Until 2013 the reported incidence of chronic kidney disease varied widely between countries, reporting the highest prevalence Taiwan, the region of Jalisco in Mexico and United States, with 458, 421 and 363 individuals per…
- Trial name
- NCT04247087
- Testing
- phytomenadione
- Where
- Mexico
- Volunteers
- 60 people
- Sponsor
- Instituto Mexicano del Seguro Social
Coronary Arterial Disease (CAD), Calcific Coronary Arteriosclerosis
Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon
The purpose of this clinical study is to evaluate the effectiveness and safety of a specialized medical device, the Naviscore scoring balloon, in preparing calcified coronary artery narrowings before the implantation of a…
- Trial name
- MILOU (NCT07650578)
- Testing
- Scoring Balloon PTCA Catheter, Non-Compliant (NC) Angioplasty Balloon
- Where
- 14 sites in Belgium, Luxembourg and 2 more
- Volunteers
- 200 people
- Sponsor
- University of Mons
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Calcified Atheroma, Coronary Artery Disease
ShOckwave ballooN or Atherectomy With Rotablation in Calcified Coronary Artery Lesions, the SONAR Trial
Percutaneous coronary interventions (PCI) is intended to relieve myocardial ischemia by improving blood flow in the epicardial coronary arteries.
- Trial name
- SONAR (NCT05208749)
- Testing
- Rotablation of shockwave
- Where
- Belgium
- Volunteers
- 170 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Atherosclerotic Cardiovascular Disease (ASCVD), Coronary Artery Calcification
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.
- Trial name
- HEARTWISE (NCT07355894)
- Testing
- AI-Detected CAC Notification and Care Facilitation
- Where
- 6 sites in United States
- Volunteers
- 120,000 people
- Sponsor
- Stanford University
Cardiovascular Diseases
ASpirin Use and stAtin Strategy for Primary Prevention in Severe Coronary Calcium Score on Computed Tomography
The primary objective of the ASA-3C trial is to evaluate the role of aspirin and high-intensity statin therapy, respectively, in individuals with severe coronary calcification (coronary calcium score ≥300) to prevent…
- Trial name
- ASA-3C (NCT06676280)
- Testing
- Aspirin, High-intensity statin, Guideline-directed statin therapy
- Where
- 32 sites in South Korea
- Volunteers
- 5,000 people
- Sponsor
- Jung-min Ahn
Treatment in Calcified Coronary Disease
Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial
The Short-Cut trial is a prospective, investigator-initiated, multicenter, randomized controlled trial that is designed to compare the efficacy of cutting balloon angioplasty vs.
- Trial name
- Short-Cut (NCT06089135)
- Testing
- Intravascular Lithotripsy, Cutting Balloon
- Where
- 22 sites in United States
- Volunteers
- 413 people
- Sponsor
- Baim Institute for Clinical Research
Renal Transplant
Effects of Zortress® + Tacrolimus vs. Standard Immunosuppression on Progression of Coronary Artery Calcifications and Bone Disease in de Novo Renal Transplant Recipients
Primary objectives: A. To evaluate the effect of Zortress® versus standard immunosuppression therapy on progression of CAC as evidenced by changes in Agatston scores from baseline and at 6, and 12 months in renal transplantation…
- Trial name
- NCT01612299
- Testing
- Zortress® /Everolimus
- Where
- United States
- Sponsor
- University of Kentucky
Calcified Coronary Artery Disease
ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2
The ISAR-CALC 2 trial is an investigator-initiated, prospective, randomized, multicenter, assessors-blind, open-label other clinical investigation.
- Trial name
- ISAR-CALC2 (NCT05072730)
- Testing
- Super High Pressure Balloon (OPN NC), Intravascular lithotripsy (IVL)
- Where
- 6 sites in Germany
- Volunteers
- 80 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Coronary Artery Disease, Myocardial Infarction
Disrupt CAD IV With the Shockwave Coronary IVL System
The study design is a prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries…
- Trial name
- NCT04151628
- Testing
- Lithotripsy
- Where
- 8 sites in Japan
- Volunteers
- 72 people
- Sponsor
- Shockwave Medical, Inc.
Calcinosis, Arteriosclerosis
CARE-2 (Calcium Acetate [PhosLo®]/Sevelamer[Renagel®] Evaluation Study 2) for Heart Calcification in Dialysis Patients
The purpose of the study is to evaluate the effects of two phosphate binders, PhosLo and sevelamer, on heart calcification in dialysis patients.
- Conditions
- Calcinosis, Arteriosclerosis, Hyperparathyroidism, Secondary
- Trial name
- NCT00211939
- Testing
- calcium acetate, sevelamer, atorvastatin
- Where
- United States
- Volunteers
- 203 people
- Sponsor
- Nabi Biopharmaceuticals
Coronary Artery Disease Risk Factors Multiple, Coronary Artery Disease Progression
PRE-EMPT: Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis
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.
- Conditions
- Coronary Artery Disease Risk Factors Multiple, Coronary Artery Disease Progression, Prevention & Control, Premature Atherosclerosis
- Trial name
- PRE-EMPT (NCT07232069)
- Testing
- Rosuvastatin 20 Mg Oral Tablet, Colchicine 0.5 MG Oral Tablet Once Daily
- Where
- 23 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Duke University
Coronary Artery Calcification, Angioplasty
CAlcified Lesion Intervention Planning Steered by OCT.
Calcified lesions are very frequent among coronary artery disease stenotic lesions. The prevalence of calcifications ranges from 30 to 40% (by angiography evaluation) but is higher when analyzed by intra coronary imaging.
- Trial name
- CALIPSO (NCT05301218)
- Testing
- angioplasty
- Where
- 14 sites in France
- Volunteers
- 140 people
- Sponsor
- Institut Mutualiste Montsouris
Coronary Artery Disease, Chronic Renal Failure
Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure
The current role of the rotational atherectomy is for non-dilatable coronary lesions and for severely calcified lesions that may interfere with optimal stent expansion.
- Trial name
- CRATER (NCT05353946)
- Testing
- Percutaneous coronary intervention (PCI)
- Where
- Spain
- Volunteers
- 124 people
- Sponsor
- Guillermo Galeote; MD, PhD
Atherosclerosis, Cardiovascular Diseases
Joint Determinants of Bone Density and CVD Calcification
To evaluate the relationship bone marrow density and coronary artery and aortic calcification.
- Conditions
- Atherosclerosis, Cardiovascular Diseases, Heart Diseases, Osteoporosis
- Trial name
- NCT00037414
- Volunteers
- 808 people
- Sponsor
- University of Maryland, Baltimore
Coronary Arterial Disease (CAD)
AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease
A prospective, open-label, multi-site, FIH with up to fifteen (n=15) patients to assess the safety and preliminary effectiveness of the AVS Pulse Intravascular Lithotripsy™ System (Pulse IVL™ System) when used for the treatment…
- Trial name
- POWER CAD I (NCT07510438)
- Testing
- Pulse Intravascular Lithotripsy (Pulse IVL)
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 15 people
- Sponsor
- Amplitude Vascular Systems, Inc.
Coronary Disease
The GISE (Società Italiana di Cardiologia Interventistica) - ShockCalcium Registry
The GISE-SHOCKCALCIUM Registry is an Investigator Driven Italian All Comers prospective, observational, multicenter Italian IVL registry of Calcified lesions Treated with Intravascular Lithotripsy.
- Trial name
- NCT05455515
- Testing
- IVL procedures
- Where
- Italy
- Volunteers
- 2,000 people
- Sponsor
- Fondazione GISE Onlus
Coronary Artery Calcification, Coronary Artery Disease
MAP-Calcification: MicroRNAs as Potential Biomarkers for Coronary Artery Calcification
Coronary artery disease (CAD) remains the leading cause of mortality in the UK with an estimated 80,000 fatalities in 2010. Coronary artery calcification (CAC) is associated with atherosclerotic plaque burden and cardiovascular…
- Conditions
- Coronary Artery Calcification, Coronary Artery Disease, Osteoporosis, Osteopenia
- Trial name
- NCT01992848
- Testing
- Venous blood sampling, 4-day food diary, 1 week UV dosimeter
- Where
- 2 sites in United Kingdom
- Volunteers
- 45 people
- Sponsor
- University of Surrey
Coronary Artery Disease
AI-Based CT Analysis of Coronary Plaque Evolution
This retrospective, multicenter, observational study will evaluate an artificial intelligence-based system for quantitative assessment and risk stratification of coronary atherosclerotic plaque.
- Trial name
- AI-CT-PLAQUE (NCT07886996)
- Where
- 5 sites in China
- Volunteers
- 326 people
- Sponsor
- Zhejiang Hospital