Evidence map›Paper›PMID 35460916›Full record

ReviewContemporary clinical trials2022

Are we any WISER yet? Progress and contemporary need for smart trials to include women in coronary artery disease trials.

Ana Iribarren, Márcio Augusto Diniz, C Noel Bairey Merz, Chrisandra Shufelt, Janet Wei

Abstract readReview
In one paragraph

Review in Contemporary clinical trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. Review
  4. Observational
  5. Article
  6. Review
  7. Article
  8. Article
  9. Reappraising Ischemic Heart Disease in Women.Reviews in cardiovascular medicine · 2023
    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

5 authors.

Ana IribarrenBarbra Streisand Women's Heart Center, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Márcio Augusto DinizBarbra Streisand Women's Heart Center, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.
C Noel Bairey MerzBarbra Streisand Women's Heart Center, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Chrisandra ShufeltBarbra Streisand Women's Heart Center, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Janet WeiBarbra Streisand Women's Heart Center, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA. Electronic address: janet.wei@cshs.org.

Funding

The Microvascular Aging and Eicosanoids - Women's Evaluation of Systemic Aging Tenacity (MAE-WEST) ("You are never too old to become younger!") Specialized Center for Research Excellence (SCORE)U54AG065141 · NIA · CEDARS-SINAI MEDICAL CENTER · PI BAIREY MERZ, CATHLEEN NOEL, CHENG, SUSAN · 2020 to 2024
$8.7M
Women's Ischemia Syndrome Evaluation (WISE) - Mechanisms of Coronary Microvascular Dysfunction Leading to Pre-Heart Failure with Preserved Ejection Fraction (HFpEF)R01HL146158 · NHLBI · CEDARS-SINAI MEDICAL CENTER · PI BAIREY MERZ, CATHLEEN NOEL · 2019 to 2023
$3.7M
Whole-Heart Myocardial Blood Flow Quantification Using MRIR01HL124649 · NHLBI · CEDARS-SINAI MEDICAL CENTER · PI LI, DEBIAO · 2015 to 2018
$3.3M
Myocardial Steatosis in Women with Coronary Microvascular Dysfunction: Defining the Pathway to Heart Failure with Preserved Ejection Fraction (HFpEF)R01HL153500 · NHLBI · CEDARS-SINAI MEDICAL CENTER · PI WEI, JANET · 2021 to 2025
$3.2M
CIAO-ISCHEMIA - Resubmission - 1R01HL119153 · NHLBI · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI REYNOLDS, HARMONY R. · 2014 to 2017
$1.8M
NHLBI NIH HHS R01 HL119153NHLBI NIH HHS R01 HL124649NHLBI NIH HHS R01 HL146158NHLBI NIH HHS R01 HL153500NIA NIH HHS U54 AG065141
6 · The paper itself

Abstract

Despite calls to ensure proportionate representation of both sexes in biomedical research, women continue to be underrepresented in cardiovascular disease (CVD) clinical trials. A comprehensive analysis of seven large suspected ischemic heart disease/coronary artery disease (IHD/CAD) clinical trials (PROMISE, ISCHEMIA, CIAO-ISCHEMIA, ORBITA, FAME, FAME 2 and COURAGE trial) provides understanding of contributions to barriers to enrollment of women and leads to strategies to address these barriers. Specifically, in the seven trials, enrollment of women did not exceed 27%, while numerous barriers are evident. Proposed strategies to improve women´s inclusion in clinical trials, include adding reproductive stage/estrogen status, attention to study design inclusion/exclusion criteria using female thresholds, consideration of diagnostic and intervention study design to be inclusive, increasing women and minorities in leadership positions, including sex as a biological variable (SABV) in study design and statistical analysis, and addressing social and race/ethnicity barriers. Dedicated action to actualizing these steps are needed at this time to developing diagnostic and therapeutic strategies resulting in better care and improved outcomes for CVD in women.

Indexed as

Cardiovascular DiseasesCoronary Artery DiseaseHeart DiseasesEthnicityFemaleHumansMaleMinority GroupsCoronary artery diseaseTrialsWomen

Identifiers

PMID35460916
PMCPMC9156573

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.