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Angina, Stable clinical trials

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NCT ID: NCT06400290 Not yet recruiting - Stable Angina Clinical Trials

Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina

ORBITA-MOON
Start date: May 2024
Phase: N/A
Study type: Interventional

ORBITA-MOON is a double-blinded, placebo-controlled experimental study that aims to understand how the different coronary artery stenoses contribute to overall clinical angina in patients with multi-vessel coronary artery disease. This study will investigate the symptoms conferred by each stenosis, induced by experimental ischaemia, for 60 patients with multi-vessel coronary artery disease.

NCT ID: NCT06387693 Not yet recruiting - Angina, Stable Clinical Trials

Artificial Intelligence in ANOCA

(AI)NOCA
Start date: August 2024
Phase: N/A
Study type: Interventional

Angina pectoris is diagnosed in >180.000 people in the Netherlands each year. Diagnosis in angina pectoris focuses on epicardial coronary stenosis, the identification of which may lead to guideline-directed medical therapy or revascularization. However, no such stenosis is identified in 40-70% of patients. This condition, angina with no obstructed coronary artery (ANOCA), is more prevalent in women and is related to poor quality of life, high medical expenses, and a higher incidence of adverse events. The origin of ANOCA can be evaluated during invasive coronary angiography by coronary function testing (CFT) to identify coronary vasomotor disorders. This relates to vasospasm of the coronary artery and microcirculation, or to impaired microvascular vasodilation. For the diagnosis of vasospasm, CFT needs to result in electrocardiographic signs of myocardial ischemia as part of the diagnostic criteria. This is a critical point in the diagnosis of vasospasm, as these signs can be subtle and can vary, and are therefore prone to misinterpretation. Apart from this caveat, the diagnosis approach therefore currently requires an invasive procedure for the diagnosis. This limits the broad application and hampers early identification and treatment of ANOCA. During CFT, a coronary guide wire is routinely advanced in the coronary artery which also allows obtaining an intracoronary ECG by attaching a sterile alligator clamp to a standard electrocardiogram lead. This allows continuous recording of intracoronary ECG throughout CFT on the same monitor as the routine ECG. This technique can increase sensitivity for myocardial ischemia during CFT. Further, Holter ECG monitoring allows the identification of ischemic changes in the ECG in the outpatient setting. Evidence is lacking on the patterns of myocardial ischemia that occur during spontaneous angina pectoris symptoms in ANOCA patients, and on the sensitivity of Holter ECG for this purpose. Finally, the interpretation of ischemic patterns on ECG tracings can be cumbersome, especially when changes are subtle or change from beat to beat. The use of deep learning techniques allows to automate the interpretation of ECG traces and may improve the standardized diagnosis in ANOCA.

NCT ID: NCT06325020 Not yet recruiting - Clinical trials for Coronary Artery Disease

Objective Risk Assessment in Patients With Possible Anginal Chest Pain Using Leading Technology

ORACLE
Start date: June 30, 2024
Phase:
Study type: Observational

The ORACLE study is an observational cohort study designed to explore the feasibility of providing an assessment of chest pain for patients with suspected angina within one working day of referral to specialist services. The primary objective is to determine the feasibility of delivering an objective assessment of risk for participants who have been referred by their primary care provider to the rapid access chest pain clinic with possible angina in a community setting using point of care and patient facing technologies within one working day of referral. Participants will complete a digital health questionnaire, at home, that asks about their risk factors for coronary artery disease, past medical history and their symptoms. Patients will then have a standard 12 lead ECG and perform their own personal ECG. They will then have high sensitivity cardiac troponin measured by point of care high sensitivity cardiac troponin assays as well as a core lab assay. The results of all of the above will allow patients to be started as low, intermediate or high risk for future cardiovascular events.

NCT ID: NCT06186336 Not yet recruiting - Clinical trials for Coronary Artery Disease

Feasibility of a Deep Learning-based Algorithm for Non-invasive Assessment of Vulnerable Coronary Plaque

FOCUS DL
Start date: July 2024
Phase:
Study type: Observational

The primary objective of this study is to assess the accuracy in terms of sensitivity, specificity, negative and positive predicted values of the DL-based algorithm with respect to correct identification of the plaque and associated vulnerability grade.

NCT ID: NCT05857904 Not yet recruiting - Clinical trials for Coronary Artery Disease

Clinical Outcomes of CT-FFR Versus QFR-guided Strategy for Decision-Making in Patients With Stable Chest Pain

CONFIDENT
Start date: May 2023
Phase: N/A
Study type: Interventional

This study is a multicenter, prospective, blinded (blinding of clinical evaluators), randomized controlled, event-driven non-inferiority clinical trial. Eligible subjects who meet the inclusion criteria will be registered in the central randomization system and randomized in a 1:1 ratio to either the experimental group (CT-FFR guided group) or the control group (QFR guided group).

NCT ID: NCT05246215 Not yet recruiting - Stable Angina Clinical Trials

Diagnostic Values of Galectin-3, Soluble ST2 and BNP in Predicting the Clinical Outcome of ST-Segment Elevation Myocardial Infarction Patients

Start date: March 1, 2022
Phase:
Study type: Observational

An acute ST-elevation myocardial infarction occurs due to occlusion of one or more coronary arteries, causing transmural myocardial ischemia which in turn results in myocardial injury or necrosis. Acute myocardial infarction (AMI) may lead to the development of heart failure (HF). Accessible diagnostic tools commonly used in HF such as natriuretic peptides and (NYHA) classification reflect already overt clinical HF. Troponin and creatine kinase reflect myocardial damage, but their usefulness in predicting long-term LVR is limited. Recent guidelines on HF management stressed that HF onset may be delayed or prevented through certain Interventions, such as pharmacotherapy ,post infarction rehabilitation, or modification of HF risk factors. Therefore, it is important to identify potential markers, which would be more informative of HF preclinical stages to recognize patients with an increased risk of HF onset, and to start treatment in advance (1) Gal-3 participates in inflammation and pro fibrotic pathways, while sST2 is a biomarker of inflammation, cardiac mechanical strain, and tissue fibrosis, both of which may predict LVR (2). sST is a biomarker of inflammation, cardiac mechanical strain, and tissue fibrosis(3). B_type natriuretic peptide (BNP) is elevated in acute myocardial infarction and is a quantitative biochemical marker related to the extent of infarction and left ventricular systolic dysfunction(4).

NCT ID: NCT04529148 Not yet recruiting - Clinical trials for Stable Angina Pectoris Associated With Depression

The Efficacy and Safety of Ginkgo Biloba Dropping Pills in the Treatment of Coronary Heart Disease With Stable Angina Pectoris and Depression

Start date: September 20, 2020
Phase: Phase 4
Study type: Interventional

To evaluate the clinical efficacy of Ginkgo biloba dropping pills on improving the frequency of angina pectoris and the life quality of patients with stable angina pectoris and depression symptoms on the basis of the best western medicine treatment; Study on the clinical pharmacological mechanism of Ginkgo biloba dropping pills.

NCT ID: NCT04498962 Not yet recruiting - Vascular Dementia Clinical Trials

The Effect of Danzhu Fuyuan Granule as Adjunctive Therapy for Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy: A Bayesian Basket Trial

Start date: August 2020
Phase: N/A
Study type: Interventional

This study is designed as a bayesian basket trial , which aims to evaluate the efficacy of Danzhu Fuyuan Granule in patients with Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy

NCT ID: NCT04424121 Not yet recruiting - Clinical trials for Coronary Artery Disease

CCTA, CACS and ECG Stress Testing in Patients With Suspected CAD: Precision Phenotyping and Financial Evaluation

DATASET
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

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. The convergence of information derived from exercise ECG stress test, CACS, CCTA and metabolomic profiling in artificial intelligence algorithms describes in brief the main objective of this protocol. The design of the present proposal is based on current state-of-the-art literature, incorporating, however, additional innovative elements. It is about the first randomized study to be conducted in Greece, investigating the role of CCTA and CACS in CAD diagnosis and risk assessment. Moreover, the present protocol aims to integrate information on patients' metabolomic profiling. The process of the whole information by using artificial intelligence technology will lead to the development of new risk stratification algorithms, promoting further personalized diagnostic and therapeutic approach. Regarding Greece, this is the first prospectively enrolling medical database of this scale.

NCT ID: NCT04403048 Not yet recruiting - Clinical trials for Coronary Artery Disease

Drug Coated Balloon for Side Branch Treatment vs. Conventional Approach in True Bifurcation Coronary Disease: PRO-DAVID

PRO-DAVID
Start date: October 2020
Phase: N/A
Study type: Interventional

Bifurcation lesions (BL) on coronary arteries account for 15-20 % of all performed percutaneous coronary interventions (PCI). Preferred approach for treatment of most bifurcation lesions is the stepwise provisional stent strategy with main branch-only stenting followed by provisional balloon angioplasty with or without stenting of the side branch (SB). Stenting of the side branch is indicated when the angiographic result in SB is clearly suboptimal and when flow remains reduced. Upfront use of two stent techniques may be indicated in very complex lesions with large calcified side branches ( most likely to supply at least 10% of fractional myocardial mass), with a long ostial side branch lesion (>5mm) or anticipated difficulty in accessing an important side branch after main branch stenting, and true distal LM bifurcations. From a technical point of view, we propose a "Provisional DCB approach" that differs from the standard provisional approach with obligatory SB predilation and good lesion preparation. In case of an adequate result of predilation, the procedure on the SB ends with the DCB deployment. This is followed by main branch stenting with DES, finished with POT. Final 'kissing' balloon dilation is generally not recommended because there is no advantage from final kissing with the one-stent technique. With this approach, there is no need for re-wiring, re-ballooning, side branching and wire jailing and final kissing. This technique is close to a contemporary approach to bifurcation lesions based on the fundamental philosophy of the European Bifurcation Club (EBC): keep it simple, systematic, and safe, with a limited number of stents that should be well apposed and expanded with limited overlap, with respect of the original bifurcation anatomy.