Clinical trials: Coronary Calcification
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 Calcification
CAlcified Coronary Lesions Identification & Quantification With X Rays
The CALIQX trial is a prospective, multicenter, non-randomized pilot study comparing the 3DStent and IVUS methods for quantifying native coronary calcifications.
- Trial name
- CALIQX (NCT07417150)
- Testing
- Imaging by IVUS and 3D Stent
- Where
- 3 sites in France
- Volunteers
- 30 people
- Sponsor
- RCF@ICPS
Severely Calcified Coronary Stenoses, De Novo Stenosis
Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions
Percutaneous coronary intervention (PCI) encounters challenges with calcified coronary lesions, leading to potential issues such as failed balloon dilatation, incomplete stent expansion, and increased risks of adverse events…
- Trial name
- REC-CHIPCAC (NCT06238518)
- Testing
- Intravascular Lithotripsy, Conventional lesion preparation strategy
- Where
- China
- Volunteers
- 220 people
- Sponsor
- Xijing Hospital
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 Calcification
Melatonin on Coronary Artery Calcification
We planned to evaluate the effects of melatonin on progression of coronary artery calcification (CAC) in patients with moderate calcified coronary atherosclerosis.
- Trial name
- MelonCAC (NCT03966235)
- Testing
- Melatonin 3 mg
- Where
- China
- Volunteers
- 74 people
- Sponsor
- Chinese PLA General Hospital
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
Familial Hypercholesterolemia - Heterozygous
Study of Coronary Calcification in Subjects With Autosomal Dominant Familial Hypercholesterolemia Heterozygous
Familial hypercholesterolemia (FH) is an autosomal dominant genetic disorder characterized by elevated plasma levels of LDL-C cholesterol.
- Trial name
- FH-CALC (NCT03501875)
- Testing
- CAC Score
- Where
- France
- Volunteers
- 270 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Lithotripsy, Angioplasty
Observatory on the Use of the Shockwave Medical C2 Coronary Lithotripsy System in the General Population in France.
Coronary calcified lesions will have an increasing impact in the daily practice of coronary angioplasty, considering the epidemiological explosion of factors favoring coronary calcifications, first of all diabetes.
- Conditions
- Lithotripsy, Angioplasty, Coronary Balloon
- Trial name
- France LILI (NCT05113407)
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- French Cardiology Society
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 Artery Calcification, Intravascular Lithotripsy
IVL vs ELCA for Stent Underexpantsion (IVL-ELCA DRAGON)
The IVL- ELCA DRAGON Registry is a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL ora ELCA in high-volume PCI centers.
- Conditions
- Coronary Artery Calcification, Intravascular Lithotripsy, Excimer Laser-coronary Atherectomy, Stent Restenosis
- Trial name
- DRAGON (NCT06276114)
- Testing
- Stent Underexpansion
- Where
- 20 sites in Italy, Poland
- Volunteers
- 121 people
- Sponsor
- Medical University of Silesia
Valvular Calcification, Coronary Calcification
Comparison of Phenprocoumon and Acetylsalicylic Acid (ASA)
In this open, prospective, non-randomised, parallel group, unicentric pilot-study will be compared the progress of valvular and coronary calcification with regard to the therapy with either acetyl-salicylic acid or phenprocoumon.
- Trial name
- NCT00782743
- Where
- Germany
- Volunteers
- 157 people
- Sponsor
- RWTH Aachen University
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
Aortic Valve Stenosis, Aortic Valve Calcification
SLOW-Slower Progress of caLcificatiOn With Vitamin K2
A randomized 12-month trial will include two groups of 100 individuals aged over 50 years, with asymptomatic mild to moderate Aortic valve stenosis (AVA > 1 cm2, Vmax < 4 m/s).
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Mitral Annular Calcification, Mitral Valve Calcification
- Trial name
- NCT04429035
- Testing
- Vitamin K2
- Where
- 2 sites in Greece
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- National and Kapodistrian University of Athens
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
Severe Aortic Stenosis, Valve-in-valve Procedures
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic…
- Trial name
- PARADIGM (NCT07194265)
- Testing
- TAVR with DurAVR® THV, TAVR with SAPIEN THV series or the Evolut THV series
- Where
- Denmark
- Volunteers
- 1,650 people
- Sponsor
- Anteris Technologies Ltd.
Aortic Stenosis, PCSK9 Inhibitor
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy of PCSK-9 Inhibitors in Delaying the Progression of Calcified Aortic Valve Disease
The aim of this clinical trial is to understand whether the drug PCSK9 inhibitor can slow the progression of calcific aortic valve disease and to understand the safety of the drug.
- Conditions
- Aortic Stenosis, PCSK9 Inhibitor, Calcified Aortic Valve Disease
- Trial name
- NCT06996223
- Testing
- The Group A received PCSK9 inhibitor plus statin therapy
- Volunteers
- 316 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Severe Native Calcific Aortic Stenosis, Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis
Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
VOYAGER CE Clinical Study using the Encantor TAVI System.
- Trial name
- VOYAGER CE (NCT07696182)
- Testing
- Prospective, single-arm, multi-center study.
- Volunteers
- 150 people
- Sponsor
- Abbott Medical Devices
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
Coronary Artery Disease
PREPARE-CALC-COMBO: Severely Calcified Coronary Lesions Prepared With Rotational Atherectomy and Modified Balloons
A prospective single-arm trial of rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions.
- Trial name
- NCT04014595
- Testing
- Rotational atherectomy in combination with cutting balloon
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Segeberger Kliniken GmbH