Clinical trials: Arterial Calcification
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
Post-COVID-19 Condition, Ulcerative Colitis
Emerging Indications for Hyperbaric Oxygen Treatment
This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric…
- Conditions
- Post-COVID-19 Condition, Ulcerative Colitis, Crohn Disease, Calciphylaxis
- Trial name
- NCT07240649
- Testing
- Hyperbaric oxygen treatment (HBOT), 100% Oxygen
- Volunteers
- 100 people
- Sponsor
- Jay C. Buckey Jr.
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
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
Shockwave IVL + DES
The objective of this clinical investigation is to evaluate, in a controlled setting, the 12 months safety and efficacy of the combination of Shockwave Intravascular Lithotripsy and a polymer coated Drug Eluting Stent device, for…
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Calcifications Vascular
- Trial name
- Shockwave DES (NCT05291247)
- Testing
- Peripheral lithotripsy system (Shockwave Medical)
- Where
- 6 sites in Germany
- Volunteers
- 50 people
- Sponsor
- Marc Bosiers, MD
Peripheral Arterial Disease
Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)
Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to…
- Trial name
- NCT02923193
- Testing
- Shockwave Lithoplasty® Peripheral Lithoplasty System, Medtronic IN.PACT (DCB)
- Where
- 54 sites in United States, Austria and 2 more
- Volunteers
- 306 people
- Sponsor
- Shockwave Medical, Inc.
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
Liver Cirrhosis
Roles of Hepatic Insufficiency, Hepatic Fibrosis, and Inorganic Pyrophosphate in the Progression of Arterial Calcifications
Individuals with metabolic syndrome (MetS), particularly those with type 2 diabetes (T2D), and/or metabolic dysfunction-associated steatohepatitis or MASH face an elevated risk of major cardiovascular events (MACE).
- Trial name
- PYROCALM (NCT07201649)
- Testing
- a blood test and urine sample collection.
- Where
- France
- Volunteers
- 95 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
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
Peripheral Arterial Disease
Investigational Study of SWM-831 to Treat Moderate and Severely Calcified Femoropopliteal Arteries
Disrupt PAD Japan is a prospective, multi-center, single-arm study of SWM-831 to treat moderate and severely calcified femoropopliteal arteries, prior to DCB or stenting.
- Trial name
- NCT06938854
- Testing
- Peripheral Intravascular Lithotripsy (IVL)
- Where
- 10 sites in Japan
- Volunteers
- 81 people
- Sponsor
- Shockwave Medical, Inc.
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
Coronary Artery Calcification, Arterial Stiffness
The InterVitaminK Trial - Effects of Vitamin K Supplementation on Cardiovascular, Metabolic, and Bone Health
The purpose of this study is to examine the effect of menaquinone-7 (MK-7) supplementation on cardiovascular, metabolic, and bone health.
- Trial name
- InterVitaminK (NCT05259046)
- Testing
- Menaquinone-7 (MK-7) tablet (333 µg)
- Where
- Denmark
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Bispebjerg Hospital
Coronary Artery Bypass Graft, Chronic Kidney Disease
Evaluation of the Bone Mineral Density and Muscle Mass in Patients Post Coronary Artery Bypass Graft Surgery With Chronic Kidney Disease
The purposes of this study are: (1) to compare the body composition, physical activity, physical function, and quality of life between patients with and without CKD after CABG; and (2) to analyze the relationships among body…
- Trial name
- NCT01932008
- Volunteers
- 60 people
- Sponsor
- Far Eastern Memorial Hospital
Peripheral Vascular Disease
DiRectional AthErectomy + Drug CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions
This study is designed to collect information during a procedure that is routine care for treating a blockage in a blood vessel in the upper part of the participant's leg.
- Trial name
- REALITY (NCT02850107)
- Testing
- Medtronic HawkOne® or TurboHawk™, Medtronic IN.PACT® Admiral® DCB, Medtronic Spider™ Distal Protection Device (DPD)
- Where
- 7 sites in United States
- Volunteers
- 102 people
- Sponsor
- VIVA Physicians
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
Esophageal Cancer
Laparoscopic Ischemic Conditioning Prior to Esophagectomy
This is a two center phase II prospective single-arm safety and feasibility trial for 20 patients with resectable esophageal carcinoma with an increased risk for anastomotic leakage, as based upon UCS and NASCET calcification…
- Trial name
- ISCON (NCT03896399)
- Testing
- Laparoscopic ischemic conditioning followed by esophagectomy
- Where
- 2 sites in Germany, Netherlands
- Volunteers
- 22 people
- Sponsor
- UMC Utrecht
Coronary Artery Calcifications, Intravascular Lithotripsy
Intravascular Lithotripsy Versus Rotational Atherectomy for Severe Coronary Artery Calcification: A Prospective, Multicenter, Non-inferiority Randomized Controlled Trial
Severely calcified coronary lesions represent one of the major challenges in interventional cardiology. Severe coronary calcification increases the difficulty and complexity of percutaneous coronary intervention (PCI), impedes…
- Conditions
- Coronary Artery Calcifications, Intravascular Lithotripsy, Rotational Atherectomy, Intravascular Ultrasound
- Trial name
- LIRAC (NCT07750964)
- Testing
- intravascular lithotripsy, rotational atherectomy
- Volunteers
- 190 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
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.