Clinical trials: Coronary Small Vessel Disease
Cardiogenic Shock, STEMI
Incorporating Supersaturated Oxygen in Shock
A multi-center, prospective randomized (1:1) pilot and feasibility study to evaluate the safety and feasibility of supersaturated oxygen (SSO2) therapy delivered for 60 minutes selectively into the culprit coronary artery of…
- Trial name
- ISO-SHOCK (NCT04876040)
- Testing
- SSO2 Downstream System, PCI + Impella
- Where
- 7 sites in United States
- Sponsor
- TherOx
Anterior Wall Acute Myocardial Infarction
Evaluation of Intracoronary Hyperoxemic Oxygen Therapy in Anterior Acute Myocardial Infarction Patients (IC-HOT)
The primary objective of the study is to collect confirmatory data supporting the safety and effectiveness of SSO2 Therapy in treatment of anterior acute myocardial infarction (AMI) patients who have undergone successful…
- Trial name
- IC-HOT (NCT02603835)
- Testing
- SSO2 Therapy
- Where
- 15 sites in United States
- Volunteers
- 100 people
- Sponsor
- TherOx
Non-severe Pulmonary Embolism, Pulmonary Embolism
Interest of the Chair Lift Test in the Prognostic Evaluation of Pulmonary Embolism: a Single-center Open Prospective Study
The objective of the study is to evaluate the prognostic performance of the chair lift test in the initial assessment of the severity of non-severe pulmonary embolism in hospitalized patients, in comparison with the current…
- Conditions
- Non-severe Pulmonary Embolism, Pulmonary Embolism, Non-high-risk Pulmonary Embolism, Pulmonary Embolism Acute
- Trial name
- SIT-EP (NCT06166329)
- Testing
- chair lift test
- Where
- France
- Volunteers
- 180 people
- Sponsor
- University Hospital, Rouen
Rare Diseases, Fabry Disease
Evaluation of HEArt invoLvement in Patients With FABRY Disease
This study evaluates predictors for the incidence of arrhythmias and sudden cardiac death as well as terminal heart failure in patients with Fabry disease.
- Conditions
- Rare Diseases, Fabry Disease, Fabry Disease, Cardiac Variant, Hypertrophic Cardiomyopathy
- Trial name
- HEAL-FABRY (NCT03362164)
- Where
- Germany
- Volunteers
- 650 people
- Sponsor
- Wuerzburg University Hospital
Coronary Artery Diseases
BIOFLOW-III VIP Russia Registry Orsiro Stent System
Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). Along with it, an explanatory (hypothesis-finding) problem will be investigated, whether the patient's body…
- Trial name
- NCT02247492
- Where
- 7 sites in Russia
- Volunteers
- 200 people
- Sponsor
- Biotronik Russia
Mitochondrial Disorders, Mitochondrial Genetic Disorders
North American Mitochondrial Disease Consortium Patient Registry and Biorepository (NAMDC)
The North American Mitochondrial Disease Consortium (NAMDC) maintains a patient contact registry and tissue biorepository for patients with mitochondrial disorders.
- Conditions
- Mitochondrial Disorders, Mitochondrial Genetic Disorders, Mitochondrial Diseases, Disorder of Mitochondrial Respiratory Chain Complexes
- Trial name
- NAMDC (NCT01694940)
- Where
- 17 sites in United States, Canada
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Columbia University
Cardiac Arrythmias, Valve Heart Disease
FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study
The FRAILTY-CARDIOWATCH study is investigating how well the Corsano CardioWatch 287-2, a wrist-worn medical device, can classify frailty in patients.
- Conditions
- Cardiac Arrythmias, Valve Heart Disease, Cardiac Ischemia
- Trial name
- FRAILTY-CW2 (NCT06930833)
- Testing
- Corsano CardioWatch 287-2
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Corsano Health B.V.
Angioplasty, Balloon, Coronary
COmparison of Xience PrimE Versus REsolute Integrity in Diabetes or Small Vessel Disease
The newer generation ZES (Medtronic, Minneapolis, MN, Resolute Integrity) and EES (Abbott Vascular, Abbott Park, Illinois, Xience Prime) were introduced to South Korea.
- Trial name
- COPERES (NCT01752127)
- Testing
- percutaneous coronary intervention using drug eluting stent
- Where
- South Korea
- Volunteers
- 600 people
- Sponsor
- Chonbuk National University Hospital
Atherosclerosis, Coronary Artery Disease
PROMUS Element Japan Small Vessel Trial
A non-randomized, small vessel (SV) trial at approximately 15 sites in Japan to enroll 60 patients with a de novo lesion ≤28 mm in length (by visual estimate) in a native coronary artery ≥2.25 mm to <2.50 mm in diameter (by…
- Trial name
- NCT01080261
- Testing
- PROMUS Element
- Where
- 15 sites in Japan
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
Fabry Disease
Therapeutic Implications of CMR Low Native T1 in Non-treated Non-hypertrophic Females With Fabry Disease (FD)
Females with Fabry disease are characterized by variable phenotypes regarding time of onset, severity of symptoms and progression of disease due to the random inactivation of X chromosome leading to a cellular mosaic of mutated…
- Trial name
- NATI-Fab (NCT07872852)
- Testing
- Decision tree for initiating treatment
- Where
- 12 sites in France
- Volunteers
- 60 people
- Sponsor
- University Hospital, Bordeaux
Ischemic Heart Disease
BIOFLOW-SV Portugal Registry
Assessment of the clinical safety and performance of the Orsiro drug-eluting stent in a real world setting in patients with small vessels with reference vessel diameter ≤2.75 mm
- Trial name
- BIOFLOW-SV (NCT03600961)
- Testing
- Orsiro Sirolimus Eluting Coronary Stent System
- Where
- 4 sites in Portugal
- Volunteers
- 173 people
- Sponsor
- Biotronik AG
Hypotension, Cesarean Section
"Effect of Pre-Spinal Mindfulness-Based Breathing Exercise on Hemodynamic Response in Elective Cesarean Section"
Spinal anesthesia-induced hypotension is one of the most frequent and clinically significant complications of obstetric anesthesia, occurring in up to 50-80% of parturients undergoing elective cesarean section.
- Conditions
- Hypotension, Cesarean Section, Hemodynamic Instability, Anxiety, Anticipatory
- Trial name
- BREATHE-CS (NCT07494955)
- Testing
- Mindfulness-Based Breathing Exercise
- Where
- Turkey (Türkiye)
- Volunteers
- 150 people
- Sponsor
- Aysenur Dostbil
Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM)
Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.
Non-ischemic cardiomyopathies (NICM) represent a heterogeneous group of pathologies characterized by absence of obstructive disease of the epicardial coronary vessels and distinct structural and functional changes of the…
- Conditions
- Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM), Hypertrophic Cardiomyopathy (HCM), Restrictive Cardiomyopathy
- Trial name
- AINICM (NCT06607471)
- Testing
- Support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation, Support treatment, cardiac medical treatment, aetiology-specific treatment
- Where
- Italy
- Volunteers
- 15,000 people
- Sponsor
- Scientific Institute San Raffaele
Coronary Artery Disease
Endeavor Zotarolimus - Eluting Stent in the Treatment Lesions in Small Native Coronary Arteries.
The objective of this study is to verify the safety and efficacy of the Endeavor Zotarolimus-Eluting Coronary Stent System for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of…
- Trial name
- ENDEAVORSVS (NCT00609947)
- Testing
- Endeavor Zotarolimus-Eluting Coronary Stent
- Where
- United States
- Volunteers
- 241 people
- Sponsor
- Medtronic Vascular
Fabry Disease, Cardiac Variant, Right Ventricular Hypertrophy
Myocardial Affectation in Patients With Fabry Disease Without Phenotypic Manifestation. Diagnostic Value of Biomarkers
The cardiac variant of the Fabry disease is a rare cardiomyopathy affecting 1/50000 individuals in general population. It is generally diagnosed in advanced stages of the disease, because it presents clinical features very…
- Trial name
- FAMY (NCT01442350)
- Volunteers
- 120 people
- Sponsor
- Francisco Marín Ortuño
Fabry Disease
Long Duration Holter ECG in Fabry Disease
The main objective is to assess the occurrence of cardiac arrhythmias and conduction disorders during a three-year follow-up using implantable Holter ECG monitoring in 40 patients with Fabry disease.
- Trial name
- NCT04440254
- Testing
- Implantation (subcutaneous) of a marketed miniaturized Holter ECG recording device
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Acute Myocardial Infarction, STEMI
Delivery SSO2 Therapy for 60 Min in Anterior MI Patients With PCI ≤ 6 Hours of Symptoms Onset Compared to Standard.
A multi-center randomized post-approval evaluation of delivery of intracoronary hyperoxemic supersaturated Oxygen therapy for 60 minutes in anterior AMI patients with successful reperfusion (via PCI) within 6 hours after onset of…
- Trial name
- NCT04743245
- Testing
- TherOx DownStream System, PCI
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- TherOx
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III Romania Satellite Registry
This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
- Trial name
- NCT01593059
- Where
- 4 sites in Romania
- Volunteers
- 13 people
- Sponsor
- Biotronik Vertriebs-GmbH
Coronary Disease
Randomized Trial of Coronary Angioplasty for de Novo Lesions in sMall vesSElS With Drug Eluting Balloon.
Significant lesions in small coronary arteries are frequently found (35%-50%) in patients with coronary artery disease. Independently of the type of coronary angioplasty the restenosis and the need for repeat revascularization…
- Trial name
- RAMSES (NCT01722799)
- Testing
- Drug elluting Balloon (DEB), Drug elluting coronary stent (DES)
- Where
- Spain
- Volunteers
- 97 people
- Sponsor
- Andres Iñiguez Romo, MD, PhD
Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
SWOG-9239 Reduction of Immunosuppression Plus Interferon Alfa and Combination Chemotherapy in Treating Patients With Malignant Tumors That Develop After Organ Transplant
RATIONALE: Reducing the amount of drugs used to prevent transplant rejection may help a person's body kill tumor cells. Giving biological therapy, such as interferon alfa, which may interfere with the growth of cancer cells, or…
- Trial name
- NCT00002657
- Testing
- bleomycin sulfate, recombinant interferon alfa, cyclophosphamide
- Where
- 86 sites in United States
- Volunteers
- 20 people
- Sponsor
- SWOG Cancer Research Network