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Refractory Angina Pectoris clinical trials

View clinical trials related to Refractory Angina Pectoris.

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NCT ID: NCT05711849 Recruiting - Refractory Angina Clinical Trials

Assessing the Safety and Effectiveness of Intracoronary Stem Cells in Patients With Refractory Angina

RegenCobra
Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

REGENERATE-COBRA will examine whether autologous stem cell treatment can improve angina symptoms and quality of life for patients with refractory angina. Patients will be randomised (randomly allocated with a 50:50 chance) to either the 'treatment' or the 'sham' group - they will not know which group they are in. In the 'treatment' group: - Stem cells will be collected from bone marrow in the patient's hip under local anaesthetic (a bone marrow aspiration). - Under local anaesthetic, the stem cells will be infused into the arteries that supply blood to the heart through a small tube inserted either in the wrist or the groin. - The follow-up involves a phone call at 1 month and 12 months and clinic visit at 6 months. In the 'sham' group: - A sham bone marrow aspiration is performed - a 3mm nick in the skin will be made under local anaesthetic. - A sham cell infusion is performed - a small tube is inserted either in the wrist or groin under local anaesthetic. - The follow-up involves a phone call at 1 month and 12 months and clinic visit at 6 months.

NCT ID: NCT05174572 Active, not recruiting - Clinical trials for Refractory Angina Pectoris

IMR Evaluation in Patients With Coronary Sinus Reducer Implantation (INROAD Study)

INROAD
Start date: December 3, 2021
Phase: N/A
Study type: Interventional

The INROAD is an investigator-driven, prospective, study in which patients undergoing coronary sinus reducer implantation (Reducer) for chronic refractory angina undergo evaluation of the index of microcirculatory resistance (IMR) at the time of implantation, and at 4 months follow-up

NCT ID: NCT04915157 Recruiting - Clinical trials for Spinal Cord Stimulation

Efficacy of Spinal Cord Stimulation in Patients With Refractory Angina Pectoris

SCRAP
Start date: December 21, 2021
Phase: N/A
Study type: Interventional

There are a growing number of patients with refractory angina pectoris (RAP). RAP is defined as a 'chronic condition (> three months) characterized by diffuse coronary artery disease in the presence of proven ischemia, which is not amendable to a combination of medical therapy, angioplasty or coronary bypass surgery'. These patients are severely restricted in performing daily activities due to debilitating angina complaints, leading to a decreased quality of life. Spinal cord stimulation (SCS) is a last resort treatment option for patients with RAP. SCS is a device with a lead located in the thoracic epidural space and an Implantable Pulse Generator (IPG) in the abdomen or buttock that provides neurostimulation. Four possible mechanisms explaining the beneficial effects of SCS on RAP have been described: reduction of pain perception, decreased sympathetic tone, reduced myocardial oxygen demand, and improved coronary microcirculatory blood flow. Research into the effect of SCS on RAP up to date have mainly been observational studies, with only four placebo-controlled randomized controlled trials. All studies confirm that treatment with SCS leads to a reduction in the number of angina pectoris attacks. What is currently not clear, is whether there is a placebo effect as results vary between the studies. One study looked at the effect of SCS in patients with RAP on the reduction of ischemia (using MIBI-SPECT) with no control arm. After 12 months myocardial ischemia was reduced, but not after three months of treatment. Leading to the conclusion that the reduction is myocardial ischemia was not a direct effect of SCS, but rather due to better coronary collateralization. The 2020 ESC guideline 'chronic coronary syndromes' mentions non-existing to promising levels of evidence with regard to treatment options in patients with RAP and concludes that SCS may be considered (Class IIB; level of evidence B). It concludes that 'larger RCTs are required to define the role of each treatment modality for specific subgroups, to decrease non-responder rates and ascertain benefit beyond potential placebo effects'. The aim of the current randomized controlled trial (double-blind, cross-over, placebo-controlled, single center) is to determine if high density spinal cord stimulation, a paresthesia free form of stimulation, leads to a significant reduction in myocardial ischemia (using PET with Rubidium-82 as tracer) in patients with refractory angina pectoris. All patients included in this study will receive an implanted spinal cord stimulator after a positive TENS treadmill outcome and proven ischemia using the imaging modality PET with Rubidium-82 as tracer. Using a cross-over design all patients will have a 6 month period with high density stimulation and 6 month period of no stimulation. Randomization will determine in which order the patient receives these treatments. Both the patient and the treating physicians are blinded for this randomization process. At baseline a 6-minute walking test, the Seattle Angina Questionnaire, the RAND-36 questionnaire, the NRS scale and the CCS class will be performed/filled out. Cross-over takes place at 6 months (switch from high density stimulation to no stimulation or vice versa) prior to which the PET scan is repeated, as well as the 6-minute walking test, the Seattle Angina Questionnaire, the RAND-36 questionnaire, the NRS-scale and the CCS-class. At the end of the study period (12 months) the PET scan is repeated, as well as the 6-minute walking test, the Seattle Angina Questionnaire, the RAND-36 questionnaire, the NRS-scale and the CCS-class.

NCT ID: NCT04121845 Completed - Clinical trials for Refractory Angina Pectoris

CoROnary SinuS Reducer implantatiOn for ischemiA reDuction

CrossRoad
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Patients with refractory angina pectoris have low quality of life and reduced exertional capacity. Studies have shown that the coronary sinus reducer (CSR) implantation improves the quality of life. However, to date there are no firm objective data on improvement of exertional capacity. Studies have shown a large influence of placebo effect after interventional procedures, which is even more pronounced than in medically treated patients. As angina pectoris presents entirely subjective perception of chest discomfort, its improvement may be influenced by this effect in up to 30 %. The investigators will study weather the CSR implantation improves aerobic exertional capacity in comparison to optimal medical therapy alone. Further, the investigators will explore the extent of myocardial reversible ischemia reduction and possible influence on hrECG markers of left ventricular arrhythmogenicity. 40 patients with refractory angina CCS class (Canadian cardiovascular society) II-IV and confirmed reversible ischemia will be included. Patients will be randomized into two groups. The first group will undergo CSR implantation procedure. The second group will present a sham control group with placebo procedure. At inclusion and after 6 months the investigators will perform cardiopulmonary exercise test (CPET), single photon emission tomography for detection of reversible ischemia (SPECT), high resolution ECG (hrECG), echocardiography and asses the subjective burden of angina according to CCS score and the quality of life according to the Seattle angina Questionnaire (SAQ).

NCT ID: NCT03438500 Withdrawn - Clinical trials for Coronary Artery Disease

Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to assess the feasibility of Cardiac Shock Wave Treatment in patients with anginal chest pain and evidence of abnormal myocardial perfusion under stress in the absence of significant stenoses of the epicardial coronary arteries.

NCT ID: NCT03039751 Active, not recruiting - Clinical trials for Coronary Artery Disease

Adenovirus Vascular Endothelial Growth Factor D (AdvVEGF-D) Therapy for Treatment of Refractory Angina Pectoris

ReGenHeart
Start date: October 19, 2019
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of catheter mediated endocardial adenovirus-mediated vascular endothelial growth factor-D (AdVEGF-D) regenerative gene transfer in patients with refractory angina to whom revascularisation cannot be performed.

NCT ID: NCT02499250 Recruiting - Clinical trials for Refractory Angina Pectoris

Effect of Daily Remote Ischemic Conditioning on the Life Quality of Refractory Angina Pectoris Patients

D-RIC-RAP
Start date: January 2015
Phase: N/A
Study type: Interventional

The purpose is to test whether daily ischemic conditioning of the arms over 30 days could reduce the frequency and severity of angina pectoris and improve the life quality of refractory angina pectoris patients.

NCT ID: NCT01711099 Recruiting - Clinical trials for Refractory Angina Pectoris

Efficacy of Extracorporeal Shockwave Myocardial Revascularization

ANGEL
Start date: October 2012
Phase: N/A
Study type: Interventional

Clinical research to justify effectiveness of the Extracorporeal Shockwave Myocardial Revascularization (ESMR) Therapy for treatment of patients with reversible myocardial ischemia secondary to Coronary Artery Disease (CAD) and therapy resistant stable angina pectoris.

NCT ID: NCT01567644 Active, not recruiting - Clinical trials for Refractory Angina Pectoris

Extracorporeal Shockwave Therapy for the Treatment of Refractory Chronic Angina Pectoris

Start date: January 2008
Phase: Phase 1
Study type: Interventional

Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones. The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with refractory angina not amenable to revascularization with angioplasty or bypass surgery.

NCT ID: NCT01567592 Suspended - Clinical trials for Refractory Angina Pectoris

Extracorporeal Shockwave Therapy for the Treatment of Chronic Angina Pectoris

Start date: March 2009
Phase: Phase 1
Study type: Interventional

Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones. The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with refractory angina not amenable to revascularization with angioplasty or bypass surgery.