- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07670741
Community Blood Pressure Screening and Cardiovascular Risk Assessment in Croatia (BPSCREEN-CRO)
A Prospective Observational Study of Blood Pressure Values, Antihypertensive Medication Use and Cardiovascular Risk Factors Among Adults Attending Community-Based Public Health Screening Campaigns in Croatia
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
This prospective, observational, non-interventional study will be conducted during community-based public health blood pressure screening campaigns in Croatia. The primary objective is to determine the prevalence of elevated blood pressure among adults attending these screening activities and to describe previously diagnosed hypertension, antihypertensive medication use and associated cardiovascular risk factors.
Adults aged 18 years or older who voluntarily attend the screening activities will be invited to participate. After providing written informed consent, participants will complete a structured questionnaire including demographic characteristics, known cardiovascular risk factors, relevant medical history, current medication use and selected lifestyle factors.
Blood pressure and pulse will be measured in a seated position, after an appropriate resting period, using validated blood pressure monitors and a cuff appropriate for the participant's arm circumference. Three consecutive measurements are planned, with a short interval between measurements. For statistical analysis and classification of blood pressure values, the average of the last two available measurements will be used. If three measurements are available, the average of the second and third measurements will be calculated. If only two measurements are available, the average of the first and second measurements will be used.
Elevated blood pressure and blood pressure values in the hypertension range will be classified according to the prespecified definitions stated in the study protocol. A single elevated blood pressure measurement obtained during a public health screening campaign will not be considered sufficient to establish a diagnosis of arterial hypertension.
The study is non-interventional. The research team will not assign treatment, prescribe medication or modify existing therapy. Participants will receive information about their measured blood pressure values and general advice to repeat blood pressure measurements or contact their family physician or another healthcare professional when indicated by the measured values, reported symptoms or clinical judgment.
Participants who consent to optional short-term follow-up may be contacted by telephone or email 1 to 3 months after the baseline screening visit. Follow-up information will include whether the participant repeated blood pressure measurements, consulted a physician, underwent additional diagnostic evaluation, received a new diagnosis of hypertension or had a change in antihypertensive treatment. Participation in follow-up is voluntary and is not required for participation in the baseline screening component of the study.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Katica Cvitkušić Lukenda, MD, PhD
- Telefonní číslo: +38598556576
- E-mail: kclukenda@gmail.com
Studijní místa
-
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Brod-Posavina County
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Slavonski Brod, Brod-Posavina County, Chorvatsko, 35000
- General Hospital Dr. Josip Bencevic
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Kontakt:
- Katica Cvitkušić Lukenda, MD, PhD
- Telefonní číslo: +38598556576
- E-mail: kclukenda@gmail.com
-
Kontakt:
- E-mail: kclukenda@gmail.com
-
Vrchní vyšetřovatel:
- Katica Cvitkušić Lukenda, MD, PhD
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Age 18 years or older
- Voluntary attendance at a community-based public health blood pressure screening campaign
- Ability to understand the study information
- Signed informed consent for participation in the baseline observational study
Exclusion Criteria:
- Age under 18 years
- Inability or unwillingness to provide informed consent
- Incomplete baseline blood pressure data preventing assessment of the primary outcome
- Acute medical condition requiring immediate emergency evaluation before completion of study procedures, at the discretion of the research team
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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Community screening participants
Adults attending community-based public health blood pressure screening campaigns who provide informed consent and undergo questionnaire-based data collection and blood pressure measurement.
Participants may optionally consent to short-term follow-up by telephone or email 1 to 3 months after the baseline screening visit.
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Non-interventional measurement of blood pressure and pulse using validated blood pressure monitors, together with questionnaire-based collection of demographic characteristics, cardiovascular risk factors, medical history, medication use and lifestyle factors.
No treatment is assigned, prescribed or modified by the research team.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Prevalence of elevated blood pressure among adults attending community-based public health screening campaigns
Časové okno: Baseline screening visit
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The proportion of participants with an average systolic blood pressure of 140 millimeters of mercury (mmHg) or higher and/or an average diastolic blood pressure of 90 mmHg or higher at the baseline screening visit.
Blood pressure will be calculated as the average of the last two available measurements.
If three measurements are obtained, the average of the second and third measurements will be used.
If only two measurements are available, the average of the first and second measurements will be used.
|
Baseline screening visit
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of participants with previously known hypertension
Časové okno: Baseline screening visit
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Proportion of participants who self-report a previous diagnosis of arterial hypertension.
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Baseline screening visit
|
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Proportion of participants receiving antihypertensive medication
Časové okno: Baseline screening visit
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Proportion of participants who report current use of antihypertensive medication.
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Baseline screening visit
|
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Proportion of treated participants with elevated blood pressure at screening
Časové okno: Baseline screening visit
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Proportion of participants receiving antihypertensive medication who have elevated blood pressure based on the average of the last two available measurements at the baseline screening visit.
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Baseline screening visit
|
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Prevalence of cardiovascular risk factors
Časové okno: Baseline screening visit
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Proportion of participants reporting cardiovascular risk factors, including smoking, diabetes mellitus, dyslipidemia, obesity, chronic kidney disease and previous cardiovascular disease.
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Baseline screening visit
|
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Proportion of participants advised to contact a physician
Časové okno: Baseline screening visit
|
Proportion of participants advised to contact their family physician or another healthcare professional based on measured blood pressure values, reported symptoms or clinical judgment during the public health screening action.
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Baseline screening visit
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Distribution of antihypertensive medication classes
Časové okno: Baseline screening visit
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Distribution of reported antihypertensive medication classes, including angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, calcium channel blockers, diuretics, mineralocorticoid receptor antagonists and other antihypertensive medications.
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Baseline screening visit
|
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Follow-up outcomes among participants consenting to short-term follow-up
Časové okno: 1 to 3 months after baseline screening visit
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Among participants who consent to follow-up, the proportion reporting repeated blood pressure measurement, physician consultation, additional diagnostic evaluation, a new diagnosis of hypertension or a change in medication after the baseline screening visit.
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1 to 3 months after baseline screening visit
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
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