Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:17 AM
Study NCT ID:
NCT07427303
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2025-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Focused Echocardiography for Primary Care Physicians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D004487', 'term': 'Edema'}, {'id': 'D003371', 'term': 'Cough'}, {'id': 'D015430', 'term': 'Weight Gain'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-16', 'studyFirstSubmitDate': '2025-09-22', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical feasibility of cardiac ultrasound performed in a GP office within the specific framework of the proposed acquisition protocol.', 'timeFrame': 'The targeted ultrasound performed by the general practitioner will be reviewed by the specialist within 72 hours.', 'description': 'Concordance between the interpretation by the general practitioner and by the expert of the ECC1 examination performed by the general practitioner in his office in the study population'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age 65 and Older', 'Cardiac Risk Factors', 'Dyspnea; Cardiac', 'Oedema', 'Fatigability', 'Cough', 'Weight Gain']}, 'descriptionModule': {'briefSummary': "Our society is characterized by a steady improvement in the standard of living of its inhabitants, which is reflected, among other things, in improved healthcare and quality of life (longer life expectancy, lower infant mortality, treatment of chronic diseases, cancer plan). Many factors contribute to this, but technological innovations and therapeutic advances are the main ones. This positive overall picture should not obscure the fact that there are significant regional disparities.\n\nFor more than 15 years, the former Lower Normandy region (Calvados, Manche, and Orne), like many other regions in France, has been marked by increasingly complex access to healthcare, whether for primary care or for so-called specialty disciplines. This situation is gradually leading to the creation of medical deserts. There are many reasons for this (numerus clausus, sociological changes, urbanization of young practitioners, attraction of small rural towns by medium-sized cities), which are chronic and have no clearly identified solution.\n\nThis situation complicates patient care and, in some cases, represents a major public health challenge, such as in the treatment of heart failure (HF), which affects more than one million people in France, or 2.3% of the adult population. For 2.3 times more deaths each year than strokes and five times more than myocardial infarctions.\n\nSome healthcare innovations can reduce the consequences of these areas of stress. In the field of cardiology, recent initiatives based on the creation of specialized cardiology and telemedicine care teams have been proposed. In primary care, point-of-care solutions enable many tests to be performed on an outpatient basis. Imaging plays a central role in patient care, and ultrasound is often the first-line modality in cardiology. Technological innovations in this field have made it possible to miniaturize ultrasound machines to such an extent that some of them can now be considered POCUS (point-of-care ultrasound). Their reduced manufacturing costs, combined with the maturity of the technique, make it possible to offer simplified acquisition protocols adapted to specific questions, known as targeted clinical ultrasound.\n\nThis simplification/miniaturization of ultrasound equipment has facilitated the spread of this technique outside the field of cardiology and now allows for its use by general practitioners close to patients, specifically for screening purposes. Many diseases would benefit from early screening in order to reduce hospitalizations, mortality, and societal costs. In cardiology, this approach remains difficult because the majority of patients admitted to healthcare facilities have already developed the disease. HF is characterized by an initial silent phase which, if left untreated, inevitably leads to complications and death. It is responsible for 200,000 hospitalizations per year in France, causing the deaths of 70,000 people. Certain signs, grouped under the French acronym EPOF, appear early on and can be warning signs, but they are often vague and unfamiliar to the general public. This fact is well illustrated by the results of a survey conducted by the Heart Failure and Cardiomyopathy Group (GICC) of the French Society of Cardiology (SFC) in 2017 (5,000 subjects representative of the French population aged 18 to 80). This survey noted that two-thirds of subjects presenting four of these signs (EPOF) had not consulted a cardiologist in the 12 months prior to the questionnaire. In the majority of cases, these patients, whether asymptomatic or paucisymptomatic (EPOF), have morphological and functional abnormalities of the heart, which are the first step toward more severe complications and can be detected by cardiac echocardiography.\n\nThere is currently a favorable alignment between echocardiography as a public health need (early detection of conditions that can lead to heart failure) and frontline practitioners (general practitioners). This alignment could lead to the definition of new practices and a new care pathway. While echocardiography is technically feasible in a general practitioner's office, its implementation remains to be evaluated (HAS report). This report emphasizes the lack of data in the literature to identify use cases and clinical impact in general medicine in France."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 65 or older with no cardiac symptoms and presenting with a treated or untreated cardiovascular risk factor (hypertension and/or diabetes and/or dyslipidemia) or\n* Adult men and women presenting with one of the following signs:\n\n * Stage I-II exertional dyspnea\n * Lower limb edema\n * Unexplained fatigue\n * Weight gain\n * Unexplained cough\n * History of carpal tunnel surgery (search for signs of myocardial infiltration by cardiac amyloidosis)\n\nExclusion Criteria:\n\n* Patients with arrhythmia or ventricular or supraventricular hyper excitability.\n* Symptomatic patients:\n\n * exertional dyspnea (NYHA \\>2)\n * palpitations\n * malaise\n * chest pain\n* Obese individuals with a BMI \\>35\n* Patients with breast implants\n* Patients under guardianship, conservatorship, or legal protection\n* Patients without health insurance coverage or equivalent\n* Patients known to have heart disease\n* Patients who have had a cardiology consultation within the last 5 years\n* Subjects with known heart disease, whether monitored or not.\n* Known valvular heart disease (whether monitored or not)\n* Known coronary artery disease (whether monitored or not)'}, 'identificationModule': {'nctId': 'NCT07427303', 'acronym': 'UPCOMING', 'briefTitle': 'Focused Echocardiography for Primary Care Physicians', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': "CLINICAL FEASIBILITY OF ULTRAPORTABLE CARDIAC ULTRASOUND PERFORMED IN THE GENERAL PRACTITIONER'S OFFICE TO IDENTIFY CARDIOVASCULAR ABNORMALITIES", 'orgStudyIdInfo': {'id': '23-0197'}, 'secondaryIdInfos': [{'id': '2023-A02068-37', 'type': 'REGISTRY', 'domain': 'Agence nationale de sécurité du médicament et des produits de santé'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Targeted Echo Group', 'interventionNames': ['Device: point of care ultrasound']}], 'interventions': [{'name': 'point of care ultrasound', 'type': 'DEVICE', 'description': 'TargetedClinical Ultrasound exam', 'armGroupLabels': ['Targeted Echo Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}