[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Spanish Society of Cardiology\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":182},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,56,85,116,152],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":36,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100572699","orbital-atherectomy-vs-intravascular-lithotripsy-for-the-treatment-of-calcified-coronary-nodules-orbit-shock-100572699",false,"NCT06736665","Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).","Comparative Efficacy of Orbital Atherectomy and Intravascular Lithotripsy in the Treatment of Calcified Coronary Nodules. The ORBIT-SHOCK Pilot Study.","ORBIT-SHOCK","Inclusion Criteria:\n\n1. Patients aged ≥ 18 years.\n2. Atherosclerotic coronary artery disease with calcified nodules identified by OCT in a native vessel, eligible for percutaneous coronary revascularization.\n3. Clinical presentation of chronic coronary syndrome or acute coronary syndrome without ST elevation\\*.\n4. Distal vessel reference diameters ≥ 2.5 mm and ≤ 4.0 mm. \\* Non-culprit lesions eligible for revascularization in a staged procedure following a ST-elevation myocardial infarction (STEMI) are considered for inclusion.\n\nExclusion Criteria:\n\n1. Culprit lesions in acute coronary syndrome with ST elevation.\n2. Left main disease.\n3. In-stent restenosis lesions.\n4. Critical stenoses where it is not possible to advance the OCT catheter across the lesion after predilation with a balloon of up to 2 mm in diameter.\n5. Lesion involving a bifurcation with a secondary branch diameter ≥2 mm.\n6. Cardiogenic shock.\n7. Patients requiring cardiac surgery or percutaneous valve intervention within three months before or after angioplasty.\n8. Pregnancy.\n9. Life expectancy of less than one year.\n10. Contraindication for the use of appropriate antiplatelet therapy post-revascularization.\n11. Coronary artery disease with an indication for surgical revascularization.\n12. Advanced chronic kidney disease or anatomical characteristics that contraindicate the use of optical coherence tomography.\n13. Inability to obtain informed consent.\n14. Allergy to eggs or soy, contraindicating the use of OA.","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI).\n\nPatients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL).\n\nThe ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI). Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL).\n\nThe aim of this pilot trial is to compare PCI outcomes and the incidence of adverse events between both techniques.",[27,28,29,30,31,32,33,34,35],"Coronary Arterial Disease (CAD)","Coronary Calcification","Coronary Calcified Nodules","Orbital Atherectomy","Intravascular Lithotripsy","Optical Coherence Tomography (OCT)","Percutaneous Coronary Intervention (PCI)","Chronic Coronary Syndrome","Acute Coronary Syndrome (ACS)",[37,38,39,40,41,32,33,34,35,15,42],"Coronary arterial disease","Coronary calcification","Coronary calcified nodules","Orbital atherectomy","Intravascular lithotripsy","ORBIT SHOCK","RECRUITING","2026-04-26",{"date":46,"type":47},"2026-04-30","ACTUAL",{"date":49,"type":47},"2025-06-12",{"date":51,"type":21},"2027-12",{"name":53,"class":54},"Spanish Society of Cardiology","OTHER",6,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":4},"100574170","phase-3-nebivolol-anoca-treatment-randomized-trial-100574170","NCT06755801","Nebivolol ANOCA Treatment Randomized Trial","Microvascular Obstruction Treatment and Outcomes Randomized Study.","MOTORS","Inclusion Criteria:\n\n* Age 18 years or older.\n\n  * Presence of stable angina symptoms, defined as compatible symptoms occurring at least once weekly in the last three months.\n  * Absence of functionally significant epicardial coronary artery disease (FFR \\> 0.80).\n  * Microvascular functional study showing CFR\\\u003C 2,0 and\u002For IMR ≥ 25.\n\nExclusion Criteria:\n\n* Allergy or contraindication to the use of beta-blockers.\n* Indication for beta-blocker treatment due to another pathology.\n* Ventricular dysfunction (LVEF \\\u003C 45%).\n* Percutaneous coronary revascularization in the last 6 months.\n* History of surgical revascularization.\n* First-degree atrioventricular block or bifascicular block.\n* Presence of hemodynamically significant valvulopathy.\n* Presence of cardiomyopathy or congenital cardiac anomaly.\n* Severe renal insufficiency (eGFR \\\u003C 30 ml\u002Fmin).\n* Liver failure (history of cirrhosis or transaminase elevation \\> 3 times the upper limit of normal).\n* Pregnant or lactating women.",{"count":65,"type":21},150,[67],"PHASE3","To determine the effectiveness of the beta-blocker nebivolol in controlling symptoms and improving the quality of life in patients with angina and coronary microvascular dysfunction.",[70,71],"ANOCA - Angina With Non-obstructive Coronary Arteries","Coronary Microvascular Dysfunction (CMD)",[73,74,75],"Coronary Microvascular Disease","Betablockers","Angina","NOT_YET_RECRUITING","2024-12-31",{"date":79,"type":47},"2025-01-01",{"date":81,"type":21},"2025-04-01",{"date":83,"type":21},"2026-09-30",{"name":53,"class":54},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},"100573183","telematic-intervention-for-reversing-frailty-among-older-patients-with-aortic-stenosis-undergoing-transcatheter-aortic-valve-intervention-the-tele-frail-tavi-clinical-trial-100573183","NCT06742970","Telematic Intervention for Reversing Frailty Among Older Patients with Aortic Stenosis Undergoing Transcatheter Aortic Valve Intervention. the TELE-FRAIL TAVI Clinical Trial","Impact of a Telematic Intervention Based on Exercise, Nutrition and Education on Frailty Reversion and Prognosis Among Older Patients with Aortic Stenosis Undergoing Transcatheter Aortic Valve Intervention: the TELE-FRAIL TAVI Clinical Trial","TELEFRAIL TAVI","Inclusion Criteria:\n\n* older patients with aortic stenosis undergoing TAVI\n* baseline frailty criteria (SPPB \\\u003C10)\n\nExclusion Criteria:\n\n* unability to sign informed consent\n* unability to complete geriatric assessment\n* unability to complete follow up","75 Years",{"count":95,"type":21},206,[24],"The TELE FRAIL clinical trial is a randomized trial designed to compare, among older frail patients with aortic stenosis undergoing transcatheter valve intervention (TAVI), the impact of usual care after vs a telematic intervention (including a supervised exercise training program, nutrition and education) on frailty reversal and clinical outcomes three months after the TAVI procedure.\n\nThe trial will include older patients a with baseline frailty criteria with severe AS undergoing TAVI. A comprehensive geriatric assessment will be performed after the TAVI procedure in all patients.\n\nInclusion criteria will be: a) patients aged 75 years or older; b) severe symptomatic aortic stenosis, as defined by a mean aortic gradient≥40 mmHg and\u002For an aortic valve area \\\u003C 1cm2 measured by transtoracic echocardiography; c) performance of successful TAVI during the admission, and d) baseline frailty criteria, as defined by Short Physical Performance Battery test value \\\u003C10 and a FRAIL scale value ≥3.\n\nExclusion criteria will be: a) negative to participate in the trial; b) unability to undergo a comprehensive geriatric assessment or study related procedures ; c) unability to complete clinical follow up, and d) life expectancy lower than one year.\n\nPatients will be randomized (1:1) to intervention or control arms before hospital discharge after the TAVI procedure.\n\nPatients assigned to the intervention will undergo a telematic intervention during the first 90 days after the admission. Trained nurses form an specialized company will contact patients by videocalls at weeks 1,3,5,7,9,11 an12 months. This telematic intervention will include 1) a supervised exercise program (based on an adaptation of the VIVI-FRAIL program) during this 12 weeks; 2) nutrition intervention: The investigator team will provide patients with nutrition supplements for the first 12 weeks after the admission. Patients will take daily a dose of 200 ml of hypercaloric hyperproteic supplements one hour after performing the corresponding exercise training session. Patients will also receive information about the optimal dieta adapted to their clinical profile; and c) health education about the disease, the importance of adherence to medical treatments and recommendations and the best measures for preventing complications.\n\nMain outcome measured will be the proportion of patients with frailty (as measured by a Short Physical Performance Battery test value \\\u003C10) 3 months after the admission.\n\nSecondary outcomes will include 1) the number of days alive out of hospital during the first year, 2) need for readmission at 3 months and at one year, 3) overall mortality at one year, 4) incidence of cardiovascular events (myocardial infarction, need for unplanned revascularization or stroke) at 3 months and at one year, 5) proportion of frail patients (SPPB\\\u003C10) at one year, 6)disability for acitivies of daily living (Barthel index) at three months and at one year, 7) nutritional risk (as measured by the MA-Sf test) at three months and at one year and 8) quality of life (as defined by the EQ-5D-5L test) at three months and at one year.",[99],"Aortic Stenosis",[101,102,103,104,105,106],"frailty","aortic stenosis","TAVI","exercise","nutrition","older","2024-12-15",{"date":109,"type":47},"2024-12-19",{"date":111,"type":21},"2025-01",{"date":113,"type":21},"2025-12",{"name":53,"class":54},1,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":128,"conditions":129,"keywords":134,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":115},"100555206","phase-4-beta-blockers-in-takotsubo-syndrome-study-100555206","NCT06509074","Beta-Blockers in Takotsubo Syndrome Study","Beta-Blockers in Takotsubo Syndrome Study: A Randomized Clinical Trial (β-Tako)","β-Tako","Inclusion Criteria:\n\n* Written informed consent.\n* Diagnosis of TTS with exclusion of significant coronary artery disease (CAD) by invasive coronary angiography\n\nExclusion Criteria:\n\n* Patients diagnosed of TTS \\> 48 hours before.\n* Persistent ccardiogenic shock or severe hemodynamic instability\n* Persistent severe (\\>30 mmHg) intraventricular gradient\n* Previous diagnosis of severe valvular or ventricular disease or prior myocardial infarction secondary to atherosclerotic CAD\n* Patients already receiving treatment with betablockers (\\*)\n* Absolute contraindication\u002Findication for beta-blockers (\\*\\*)\n* Poor echocardiographic window\n* Pregnant or breastfeeding women.\n* Participation in another clinical trial.\n\n(\\*) Betablockers at a therapeutic dose at the time of symptom´s onset. (\\*\\*) Close ECG monitoring required in patients with hypotension, bradycardia or cQT interval prolongation",{"count":125,"type":21},200,[127],"PHASE4","The Beta-blockers in Takotsubo syndrome (TTS) (β-Tako) trial, is an academic, pragmatic, prospective, multicenter randomized clinical trial, aiming to assess the efficacy of beta-blockers (BB) in TTS patients. Two-hundred patients with TTS will be randomized (1:1) to BB (n=100) or no BB (n=100). BB with alpha or nitric oxide release activity will be used in the treatment arm. The primary endpoint will be the comparison of the wall motion score index by echocardiography at 7 days. A composite clinical endpoint (death, stroke, admission for recurrent TTS, ACS, heart failure or atrial fibrillation) at 1 year, will be assessed by an independent clinical events committee. Several sub-studies will be performed. The β-Tako trial will inform treatment decisions in this uniquely challenging clinical entity.",[130,131,132,133],"Takotsubo Cardiomyopathy","Beta-blockers","Echocardiography","Left Ventricular Function",[130,135,136,137,138,139,140,141,142,143],"beta-blockers","echocardiography","left ventricular function","acute myocardial infarction","acute coronary syndrome","coronary angiography","Normal coronary arteries","Heart failure","stress","2024-08-21",{"date":146,"type":47},"2024-08-26",{"date":148,"type":21},"2024-08",{"date":150,"type":21},"2026-12",{"name":53,"class":54},{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":4},"100427777","phase-4-randomized-study-of-beta-blockers-and-antiplatelets-in-patients-with-spontaneous-coronary-artery-dissection-100427777","NCT04850417","Randomized Study of Beta-Blockers and Antiplatelets in Patients With Spontaneous Coronary Artery Dissection","Randomized Clinical Trial Assessing the Value of Beta-Blockers and Antiplatelet Agents in Patients With Spontaneous Coronary Artery Dissection. (The BA-SCAD Randomized Clinical Trial)","BA-SCAD","Inclusion Criteria:\n\n* Angiographic diagnosis of SCAD\n* Admission for ACS or other manifestations of ischemia\n* Informed consent\n\nExclusion Criteria:\n\n* Cardiogenic shock or severe hemoynamic instability\n* Concomitant severe heart disease requiring surgical correction (in \\\u003C2 years)\n* Medical condition seriously limiting life expectancy (\\\u003C 2 years)\n* Allergies or contraindication to drugs required in one of the study arms; the patient may be randomized in the other arm (factorial design)","90 Years",{"count":162,"type":21},600,[127],"Spontaneous coronary artery dissection (SCAD) is a cause of acute coronary syndrome (ACS). Most patients are treated with beta-blockers (BB) and antiplatelet drugs (AP) on empiric basis. The Beta-Blockers and Antiplatelet Agents in Patients with Spontaneous Coronary Artery Dissection (BA-SCAD) randomized clinical trial is an academic, pragmatic, nation-wide, prospective study developed under the auspices of the Spanish Society of Cardiology (SEC) that aims to assess the efficacy of medical therapy in SCAD patients. Using a factorial 2x2 design, patients will be randomized (1:1\u002F1:1) to: 1) BB (yes\u002Fno) and 2) short AP regimen (1 month) vs prolonged dual AP therapy (DAPT) (12 months).Only patients with preserved left ventricular ejection fraction (LVEF) will be randomized to BB (yes\u002Fno) because patients with LVEF \\\u003C40% will receive BB according to current guidelines. Likewise, only medically managed patients will be randomized to short AP therapy vs 1-year DAPT. The study will have a pragmatic, open label, blind outcomes design (PROBE). A total of 600 SCAD patients will be randomized within 2 years (300 per arm in a factorial 2x2 design). The primary efficacy endpoint will include the composite of death, acute myocardial infarction (MI), stroke, coronary revascularization, recurrent SCAD, and unplanned hospitalization for ACS or heart failure at 1 year. The primary safety endpoint will be bleeding. All patients will be clinically followed yearly. The main study will be pragmatic but a comprehensive set of additional studies (clinical, imaging, biomarkers, inflammatory, immunologic, pharmacogenetic and genetic) will be organized to ensure an holistic view on this challenging condition.",[166],"Spontaneous Coronary Artery Dissection",[168,131,169,170,171,172,173],"Spontaneous coronary artery dissection","Antiplatelets","Coronary angiography","Intracoronary imaging","Biomarkers","Myocardial infarction","2021-04-14",{"date":176,"type":47},"2021-04-20",{"date":178,"type":21},"2021-04-30",{"date":180,"type":21},"2028-12-31",{"name":53,"class":54},""]