Evidence map›Paper›PMID 26554661›Full record

Trial reportCoronary artery disease2016

The Cardiovascular Trial of the Testosterone Trials: rationale, design, and baseline data of a clinical trial using computed tomographic imaging to assess the progression of coronary atherosclerosis.

Moshrik Abd Alamir, Susan S Ellenberg, Ronald S Swerdloff, Nanette K Wenger, Emile R Mohler, Cora E Lewis, Elizabeth Barrett-Conner, Rine Nakanishi, Sirous Darabian, Anas Alani and 4 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Coronary artery disease, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00799617 (Randomized, Placebo-controlled, Double-blind Study of Seven Coordinated Testosterone Treatment Trials in Older Men), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT00799617 phase3completednot on this map

Randomized, Placebo-controlled, Double-blind Study of Seven Coordinated Testosterone Treatment Trials in Older Men

TypeinterventionalSponsorUniversity of PennsylvaniaRan2009 to 2018Enrolled790ConditionsAndropauseArmsAndroGel® (testosterone gel), Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Testosterone replacement in men with sexual dysfunction.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Review
  10. Review
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

14 authors.

Moshrik Abd AlamiraLos Angeles Biomedical Research Institute at Harbor-UCLA, Torrance, California bCenter for Clinical Epidemiology & Biostatistics cDivision of Cardiovascular Disease and Section of Vascular Medicine dDivision of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania eDepartment of Medicine, Division of Cardiology, Emory University School of Medicine, Emory Heart and Vascular Center, Atlanta, Georgia fDivision of Preventive Medicine, University of Alabama at Birmingham, Birmingham, Alabama gDepartment of Family and Preventive Medicine, Division of Epidemiology, University of California San Diego, La Jolla, California hCardiology Department, University of Florida, Gainesville, Florida, USA.
Susan S Ellenberg
Ronald S Swerdloff
Nanette K Wenger
Emile R Mohler
Cora E Lewis
Elizabeth Barrett-Conner
Rine Nakanishi
Sirous Darabian
Anas Alani
Suguru Matsumoto
Negin Nezarat
Peter J Snyder
Matthew J Budoff

Funding

Testosterone TrialU01AG030644 · NIA · UNIVERSITY OF PENNSYLVANIA · PI SNYDER, PETER J. · 2009 to 2015
$32.4M
University of Alabama at Birmingham's Diabetes Research CenterP30DK079626 · NIDDK · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Kirk Michael Habegger · 2013 to 2026
$19.5M
UAB Diabetes Research and Training CenterP60DK079626 · NIDDK · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI GARVEY, W TIMOTHY · 2008 to 2012
$8.4M
STUDY OF RISK FACTORS FOR OSTEOPOROSIS IN THE ELDERLYR37AG007181 · NIA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BARRETT-CONNOR, ELIZABETH L · 1987 to 2010
$5.4M
The Bone Trial of the Testosterone TrialR01AG037679 · NIA · UNIVERSITY OF PENNSYLVANIA · PI SNYDER, PETER J. · 2011 to 2015
$2.9M
ENDOCRINOLOGY, METABOLISM &NUTRITION TRAINING GRANTT32DK007571 · NIDDK · LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER · PI SWERDLOFF, RONALD SHERWIN · 1988 to 2013
$2.1M
GENDER DIFFERENCES IN OSTEOPOROSISR01AG007181 · NIA · UNIVERSITY OF CALIFORNIA SAN DIEGO · PI BARRETT-CONNOR, ELIZABETH L · 1999 to 2002
$1.6M
CVD Predictors of Cognitive Function Trajectory over 20 YearsR01AG028507 · NIA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BARRETT-CONNOR, ELIZABETH L · 2007 to 2010
$1.2M
EPIDEMIOLOGY OF NIDDM AND IGT IN AN ADULT COMMUNITYR01DK031801 · NIDDK · UNIVERSITY OF CALIFORNIA SAN DIEGO · PI BARRETT-CONNOR, ELIZABETH L · 1986 to 2000
$606k
NIA NIH HHS 5-U01-AG030644NIA NIH HHS AG028507NIA NIH HHS AG07181NIA NIH HHS R01 AG007181NIA NIH HHS R01 AG028507NIA NIH HHS R01 AG037679NIA NIH HHS R37 AG007181NIA NIH HHS U01 AG030644NIDDK NIH HHS DK-079626NIDDK NIH HHS P30 DK079626NIDDK NIH HHS P60 DK079626NIDDK NIH HHS R01 DK031801NIDDK NIH HHS T32 DK007571NIDDK NIH HHS T32-DK007571
6 · The paper itself

Abstract

backgroundData from prior studies have yielded inconsistent results on the association of serum testosterone levels with the risk for cardiovascular disease. There are no clinical trial data on the effects of testosterone replacement therapy on plaque progression.

objectiveWe designed a study to investigate the effect of testosterone therapy on coronary artery plaque progression using serial coronary computed tomographic angiography (CCTA). In this paper, we describe the study design, methods, and characteristics of the study population.

methodsThe Cardiovascular Trial of the Testosterone Trials (TTrials; NCT00799617) is a double-blind, placebo-controlled trial of 1 year of testosterone therapy in men 65 years or older with clinical manifestations of androgen deficiency and unequivocally low serum testosterone concentrations (<275 ng/dl). CCTA performed at baseline and after 12 months of therapy will determine the effects of testosterone on the progression of the total volume of noncalcified plaques. All scans are evaluated at a central reading center by an investigator blinded to treatment assignment.

resultsA total of 165 men were enrolled. The average age is 71.1 years, and the average BMI is 30.7. About 9% of men had a history of myocardial infarction, 6% angina, and 10% coronary artery revascularization. A majority reported hypertension and/or high cholesterol; 31.8% reported diabetes. Total noncalcified plaque at baseline showed a slight but nonsignificant trend toward lower plaque volume with higher serum testosterone concentrations (P=0.12).

conclusionThe Cardiovascular Trial will test the hypothesis that testosterone therapy inhibits coronary plaque progression, as assessed by serial CCTA.

Indexed as

AgedAndrogensCoronary AngiographyCoronary Artery DiseaseDisease ProgressionDouble-Blind MethodHormone Replacement TherapyHumansHypogonadismMaleTestosteroneTomography, X-Ray ComputedAndrogensTestosterone

Identifiers

PMID26554661
PMCPMC4738150

What OpenQuestion holds

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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.