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| Sponsor: | University of Roma La Sapienza |
|---|---|
| Information provided by: | University of Roma La Sapienza |
| ClinicalTrials.gov Identifier: | NCT01161251 |
Purpose
Atrial fibrillation (AF) is the most common sustained dysrhythmia encountered in clinical practice in North America and Europe, accounting for approximately one-third of all hospitalizations for a cardiac rhythm abnormality. The presence of AF markedly increases the patient's risk for developing arterial embolism and stroke, depending on the presence of other clinical conditions, such as hypertension and diabetes. AF is associated with a fivefold increased risk for stroke, and is estimated to cause 15% of all strokes.
Patients with AF frequently have several risk factors for atherosclerosis, including hypertension, diabetes, and dyslipidemia. Accordingly, systemic signs of atherosclerosis can be detected in AF patients, and these likely accounts for an enhanced risk of coronary heart disease. In addition to cerebrovascular disease, patients with AF may suffer from coronary events including myocardial infarction (MI), but the rate of MI in AF patients seems to be variable, but often underestimated.
Moreover, coexistence of peripheral arterial disease (PAD) is a relevant clinical sign of systemic atherosclerosis.
Ankle-brachial index (ABI) is a simple, inexpensive, and non-invasive PAD measurement, even at the pre-symptomatic phase when intervention can improve prognosis and prevent or delay severe complications ABI is calculated by measuring the systolic blood pressure in the posterior tibial and/or the dorsalis pedis arteries either in both legs or 1 leg chosen at random (using a Doppler probe or alternative pulse sensor), with the lowest ankle pressure then divided by the brachial systolic blood pressure. In addition to peripheral artery disease, the ABI also is an indicator of generalized atherosclerosis because lower levels have been associated with higher rates of concomitant coronary and cerebrovascular disease, and with the presence of cardiovascular risk factors.
Two large studies in patients with AF document the existence of PAD in about 3-5% of patients. It is possible, however, that such an incidence has been underestimated as only symptomatic patients were considered as affected by PAD. As PAD is an important marker of systemic atherosclerosis, its association with AF reinforces the concept that patients with AF have systemic atherosclerosis that potentially account for coronary complications.
To date, a national registry of AF patients is not available to verify the real impact of cardiovascular events in this clinical setting.
| Condition |
|---|
|
Atrial Fibrillation Peripheral Vascular Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Atrial Fibrillation Registry for Ankle-brachial Index Prevalence Assessment: Collaborative Italian Study. |
| Estimated Enrollment: | 3000 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Atrial fibrillation patients
Non-valvular atrial fibrillation (paroxysmal, persistent or permanent)
|
Study design: Prospective longitudinal study
Methods and Materials: The investigators planned to assess at baseline and at scheduled follow up visits :
Subgroups analysis will be also conducted for patients with first onset of AF or recurrent AF Sample size: The investigators plan to include in the study n = 3,000 patients, with competitive recruitment between centers involved in the study. The sample size was calculated assuming an expected prevalence of 19% at time zero, and in order to obtain a confidence interval 95% to prevail at time zero whose distance from the edge is less than or equal to 1.4%.
This sample size yields a power greater than 99.9% for the secondary endpoint, assuming an event rate of 19% for patients with ABI <= 0.9, and 10% for patients with ABI > 0.9
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
The investigators plan to include in the study n = 3,000 AF patients, with competitive recruitment between centers involved in the study. The sample size was calculated assuming an expected prevalence of 19% at time zero, and in order to obtain a confidence interval 95% to prevail at time zero whose distance from the edge is less than or equal to 1.4%.
This sample size yields a power greater than 99.9% for the secondary endpoint, assuming an event rate of 19% for patients with ABI <= 0.9, and 10% for patients with ABI > 0.9
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Francesco Violi, MD | +39-06-4461933 | francesco.violi@uniroma1.it |
| Contact: Giovanni Davì, MD | +39-0871-541312 | gdavi@unich.it |
| Italy | |
| Sapienza - University of Rome and SIMI | Recruiting |
| Rome, Italy, 00161 | |
| Contact: Francesco Violi, Full Prof +39-06-4461933 francesco.violi@uniroma1.it | |
| Contact: Stefania Basili, Ass Prof +39-06-49974678 stefania.basili@uniroma1.it | |
| Principal Investigator: Francesco Violi, MD | |
| Principal Investigator: Giovanni Davì, MD | |
| Società Italiana di Medicina Interna | Recruiting |
| Rome, Italy, 00161 | |
| Principal Investigator: Francesco Violi, MD | |
| Sub-Investigator: Giovanni Davì, MD | |
| Study Chair: | Francesco Violi, Full Prof | Divisione di Prima Clinica Medica - Sapienza University of Rome and SIMI |
More Information
| Responsible Party: | Francesco Violi, Prima Clinica Medica - Atherothrombosis Center |
| ClinicalTrials.gov Identifier: | NCT01161251 History of Changes |
| Other Study ID Numbers: | SIMI-ARA PACIS |
| Study First Received: | July 12, 2010 |
| Last Updated: | March 22, 2011 |
| Health Authority: | Italy: Ethics Committee |
|
Atrial Fibrillation ABI PAD Registry Italian |
|
Atrial Fibrillation Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Pathologic Processes Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases |