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Lin JS, Olson CM, Johnson ES, et al. The Ankle Brachial Index for Peripheral Artery Disease Screening and Cardiovascular Disease Prediction in Asymptomatic Adults: A Systematic Evidence Review for the U.S. Preventive Services Task Force [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Sep. (Evidence Syntheses, No. 100.)

Appendix COngoing Studies and Trials Pending Assessment

Study referenceStudy name NCT #Relevant KQ Study designAimLocation# of participants Inclusion criteriaIntervention descriptionRelevant outcomes2012 Status
Grøndal N et al. The Viborg Vascular (VIVA) screening trial of 65–74 year old men in the central region of Denmark: study protocol. Trials. 2010;11:67. PMID: 20507582Viborg Vascular Screening Trial (VIVA)

00662480
KQ 1

RCT
To establish the effectiveness of a joint circulation screening program (AAA, ABI, hypertension)Denmark40,000

Men ages 65 to 74 years
IG: Invitation to screening ultrasound of the aorta and ABI; interventions (risk factor reduction or AAA surgery) for those who screen positive
CG: No invitation to screening; usual care
All-cause mortality, cardiovascular and AAA-related mortality; cardiovascular events at 3, 5, and 10 yearsCurrently recruiting participants
Estimated primary completion date: September 2018
Marti R et al. Improving intermediate risk management. MARK study. BMC Cardiovasc Disord. 2011;11:6. PMID: 21992621Improving Intermediate Risk Management (MARK)

01428934
KQ 4

Cohort
To analyze if ABI and other cardiovascular biomarkers are independently associated with incidence of vascular events and if they improve the prediction of current risk equations in the intermediate-risk populationSpain2,688

Men and women ages 35 to 74 years with intermediate cardiovascular risk by FRS or SCORE
ABI along with other cardiovascular biomarkers and CVD screening testsVascular events (fatal or nonfatal): MI, angina, stroke, or PAD at 18 months and 10 yearsCurrently recruiting participants
Estimated primary completion date: January 2013
Muntendam P et al. The Bioimage Study: novel approaches to risk assessment in the primary prevention of atherosclerotic cardiovascular disease—study design and objectives. Am Heart J. 2010;160(1):49-57. PMID: 20598972BioImage

00738725
KQ 4

Cohort
To identify imaging and serum biomarkers that predict atherothrombotic events after 3 years, with incremental improvement over the FRSChicago, IL; Louisville, KY; and Ft. Lauderdale, FL7,687

Men age >55 years and women age >60 years who are members of the Humana Health Plan
IG: CAC score; cIMT, carotid atherosclerotic

Plaques, and AAA by ultrasound; ABI; and serum biomarkers; those with abnormal results are offered MRA, CTA, or PET/CT

CG1: Survey only
CG2: FRS only
MI (fatal and nonfatal), coronary death, unstable angina, ischemic stroke (fatal and nonfatal), and arterial revascularization at 3 years or when 600 major atherothrombotic events have occurredOngoing but not recruiting participants
Estimated study completion date: July 2012
Evaluation of Non-invasive Measurements of Atherosclerosis in Cardiovascular Risk Stratification (NIMA)NIMA

Substudy of Nijmegen Biomedical Study

01555294
KQ 4

Cohort
To evaluate whether noninvasive measurements of atherosclerosis are independent predictors of cardiovascular diseaseThe Netherlands1,960

Men and women ages 50 to 70 years without recent CVD
Noninvasive measurements of atherosclerosis (including ABI)Cardiovascular events (fatal and nonfatal)Completed
May 2011
No study results posted on ClinicalTrials​.gov or retrieved through PubMed
Casasnovas JA et al. Aragon workers' health study: design and cohort description. BMC Cardiovasc Disord. 2012;12:45. PMID: 22712826Aragon Workers' Health Study

(NR)
KQ 4

Cohort
To characterize the factors associated with metabolic abnormalities and subclinical atherosclerosis in a middle-aged population in Spain free of clinical cardiovascular diseaseAragon, Spain5,400

Male and female workers of a large car assembly plant without clinically overt CVD or a condition limiting survival to <3 years
Subclinical atherosclerosis imaging (including ABI; CAC; and ultrasound of the carotid, aortic, femoral and iliac arteries); biobankingClinical events and hospitalizationsRecruitment and baseline examinations 2009–2010; planned 10 years' followup
Estimated study completion date: 2020
Early detection of atherosclerosis: a randomized trial in the Primary Prevention of Cardiovascular Diseases. (PRIMARIA)

http://www​.udetma.com​/documents/productes/pdf/38_1.pdf
PRIMARIA

00734123
KQ 5

RCT
To quantify the burden of subclinical atherosclerosis using noninvasive techniques and to study the impact of this assessment and consequent treatment in the progression of atherosclerosis and in the incidence of cardiovascular diseasesVilanova, Spain2,948

Men and women ages 40 to 74 years without history of cardiovascular events but with 1 major or 2 minor risk factors for CAD
All participants have cIMT (or CAC score, if problems measuring cIMT) and ABI. Those with abnormal results are randomized:
IG: Intensive treatment
CG: Usual care
cIMT/CAC score at 2 years
Incidence of CVD at 5 years
Secondary analysis will examine ABI at 2 years as outcome
Currently recruiting participants

Abbreviations: AAA = abdominal aortic aneurysm; ABI = ankle-brachial index; CAC = coronary artery calcium; CAD = coronary artery disease; CG = control group; cIMT = carotid intima media thickness; CTA = computed tomography angiography; CVD = cardiovascular disease; FRS = Framingham risk score; IG = intervention group; KQ = key question; MI = myocardial infarction; MRA = magnetic resonance angiography; PAD = peripheral artery disease; PET = positron emission tomography; RCT = randomized, controlled trial.

Cover of The Ankle Brachial Index for Peripheral Artery Disease Screening and Cardiovascular Disease Prediction in Asymptomatic Adults: A Systematic Evidence Review for the U.S. Preventive Services Task Force
The Ankle Brachial Index for Peripheral Artery Disease Screening and Cardiovascular Disease Prediction in Asymptomatic Adults: A Systematic Evidence Review for the U.S. Preventive Services Task Force [Internet].
Evidence Syntheses, No. 100.
Lin JS, Olson CM, Johnson ES, et al.

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