Evidence map›Paper›PMID 22381072›Full record

Trial reportBMC research notes2012

Randomised clinical trial of an intensive intervention in the primary care setting of patients with high plasma fibrinogen in the primary prevention of cardiovascular disease.

Juan José Rodríguez Cristóbal, Carlos Alonso-Villaverde Grote, Pere Travé Mercadé, José Ma Pérez Santos, Esther Peña Sendra, Anna Muñoz Lloret, Cristina Fernández Pérez, Domingo Bleda Fernández, EFAP group

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC research notes, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01089530 (Clinical Intervention Study in the Primary Care Setting of Patients With High Plasma Fibrinogen in Primary Prevention of Cardiovascular Disease), which is not on this map. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 pooled it
0.2field-weighted citation impact, top 41% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01089530 nacompletednot on this map

Clinical Intervention Study in the Primary Care Setting of Patients With High Plasma Fibrinogen in Primary Prevention of Cardiovascular Disease

TypeinterventionalSponsorFundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaRan2003 to 2006Enrolled436ConditionsCardiovascular Risk FactorsArmsLifestyle intensive group
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 syntheses or guidelines pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 1 country.

Juan José Rodríguez CristóbalMedicina, Area Básica Salud Florida Sud, Parc dels Ocellets, L'Hospitalet del Llobregat, Barcelona, Spain. 21002jrc@comb.es
Carlos Alonso-Villaverde Grote
Pere Travé Mercadé
José Ma Pérez Santos
Esther Peña Sendra
Anna Muñoz Lloret
Cristina Fernández Pérez
Domingo Bleda Fernández
EFAP group
Ajuntament de L’Hospitalet · ESInstitut Català de Ciències del Clima · ESAbbott (Spain) · ESHospital Clínico San Carlos · ESHospital de Viladecans · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe have studied the possible effects of an intensive lifestyle change program on plasma fibrinogen levels, in patients with no cardiovascular disease, with elevated levels of fibrinogen, normal cholesterol levels, and a moderate estimated risk of coronary heart disease (CHD) and we have also analysed whether the effect on fibrinogen is independent of the effect on lipids.

resultsThis clinical trial was controlled, unblinded and randomized, with parallel groups, done in 13 Basic Health Areas (BHA) in l'Hospitalet de Llobregat (Barcelona) and Barcelona city. The study included 436 patients, aged between 35 and 75 years, with no cardiovascular disease, elevated levels of fibrinogen (> 300 mg/dl), cholesterol < 250 mg/dl, 218 of whom received a more intensive intervention consisting of advice on lifestyle and treatment. The follow-up frequency of the intervention group was every 2 months. The other 218 patients followed their standard care in the BHAs. Fibrinogen, plasma cholesterol and other clinical biochemistry parameters were assessed.The evaluation of the baseline characteristics of the patients showed that both groups were homogenous. Obesity and hypertension were the most prevalent risk factors. After 24 months of the study, statistically significant changes were seen between the adjusted means of the two groups, for the following parameters: fibrinogen, plasma cholesterol, systolic and diastolic blood pressure and body mass index.

conclusionIntensive intervention to achieve lifestyle changes has shown to be effective in reducing some of the estimated CHD factors. However, the effect of intensive intervention on plasma fibrinogen levels did not correlate with the variations in cholesterol.

trial registrationClinicalTrials.gov: NCT01089530.

Indexed as

Primary Health CarePrimary PreventionAdultAgedBlood PressureBody Mass IndexCardiovascular DiseasesCholesterolDietExerciseFemaleFibrinogenHumansHypertensionLife StyleMaleCholesterolFibrinogen

Identifiers

PMID22381072
PMCPMC3317867
OpenAlexW2128415799

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.