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Morbidity and Mortality in Patients With Hypertrophic Cardiomyopathy: a CALIBER Study (HCM)

20 апреля 2015 г. обновлено: University College, London

Morbidity and Mortality in Patients Diagnosed With Hypertrophic Cardiomyopathy: a CALIBER Study

The aim of this project is to study the association of a number of demographic and cardiovascular risk factors with death, health care utilisation and systemic embolisation by examining the clinical evolution of hypertrophic cardiomyopathy in a large, community based cohort identified from linked electronic health records.

Обзор исследования

Статус

Неизвестный

Условия

Вмешательство/лечение

Подробное описание

Most data on hypertrophic cardiomyopathy related morbidity and mortality are derived primarily from longitudinal, observational studies based at tertiary cardiac centres. It is unclear what the main causes of morbidity and death are in the general hypertropic cardiomyopathy population (outside tertiary referral centres) and it is likely that many patients have a benign clinical course and die from non-cardiac causes.

Linkage of the Clinical Practice Research Datalink (CPRD) to the Myocardial Ischaemia National Audit Project (MINAP), Hospital Episode Statistics (HES) and Office of National Statistics (ONS), offers the opportunities to study the natural history of hypertrophic cardiomyopathy, from the time of diagnosis to the end of life, health care utilisation and to investigate the association between clinical characteristics and common clinical fatal and non-fatal outcomes.

Тип исследования

Наблюдательный

Регистрация (Действительный)

12464

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

Patients registered in Clinical Practice Research Datalink (CPRD) practices

Описание

Inclusion Criteria:

  • One year or more of follow-up in the practice prior to study entry
  • 18 years or older

Exclusion Criteria:

• Unknown sex and age

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Временное ограничение
Rate ratios for the associations between hypertrophic cardiomyopathy and angina
Временное ограничение: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and unstable angina
Временное ограничение: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and myocardial infarction
Временное ограничение: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and coronary heart disease not otherwise specified
Временное ограничение: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and cardiac arrest
Временное ограничение: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and ventricular arrhythmia
Временное ограничение: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and atrial fibrillation
Временное ограничение: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and heart failure
Временное ограничение: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and transient ischemic attack
Временное ограничение: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and stroke
Временное ограничение: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and peripheral arterial disease
Временное ограничение: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and abdominal aortic aneurysm
Временное ограничение: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and systemic thromboembolism
Временное ограничение: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)

Вторичные показатели результатов

Мера результата
Временное ограничение
Rate ratios for the associations between hypertrophic cardiomyopathy and cancer
Временное ограничение: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and chronic obstructive pulmonary disease
Временное ограничение: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and liver-related
Временное ограничение: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University College, London

Соавторы

Inherited Cardiac Diseases Unit, The Heart Hospital, London

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 апреля 2015 г.

Первичное завершение (Ожидаемый)

1 декабря 2015 г.

Завершение исследования (Ожидаемый)

1 декабря 2015 г.

Даты регистрации исследования

Первый отправленный

20 апреля 2015 г.

Впервые представлено, что соответствует критериям контроля качества

20 апреля 2015 г.

Первый опубликованный (Оценивать)

23 апреля 2015 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

23 апреля 2015 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

20 апреля 2015 г.

Последняя проверка

1 апреля 2015 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 13_096R

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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