ClinicalTrials.gg
Not yet recruitingNCT05377320Updated Nov 3, 2026

PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study

An observational study in Heart Failure, Coronary Artery Disease and Peripheral Artery Disease, sponsored by Medical College of Wisconsin. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Medical College of Wisconsin · Observational

Updated Nov 3, 2026Start date movedPrimary completion moved+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

This is a single-center, double-arm, open-label, randomized feasibility study that will determine whether a novel clinical decision aid accessed via the electronic health record will be acceptable to both cancer survivors and their cardiologists, will favorably impact appropriate medication use and cardiac imaging surveillance, and will improve clinician and patient decision-making, perception, and behavior towards cardioprotective medication usage and cardiovascular disease imaging utilization.

Read the detailed description

For this feasibility study, the researchers will create the clinical decision aid and test the central hypothesis that this novel clinical decision aid accessed via the electronic health record will be acceptable to both cancer survivors and their cardiologists and will favorably impact appropriate medication use and cardiac imaging surveillance. The hypothesis is supported by preliminary data suggesting that an initial and rudimentary version of the clinical aid increases appropriate medication use and imaging follow-up in cardio-oncology patients. Success will be determined by ≥85% of clinic visits using the clinical decision aid resulting in pursuit of medication use and cardiac imaging surveillance patterns commensurate with recommendations specific to cancer survivors, with overall rates the same or higher than the group without the clinical decision aid, as well as overall favorable patient and physician focus group comments and survey responses.

02

Conditions studied

  • Heart Failure
  • Coronary Artery Disease
  • Peripheral Artery Disease
  • Ischemia
  • Hypertension
  • Diabetes Mellitus
  • Cardiomyopathies
  • Cardiotoxicity

Keywords

  • clinical decision aid
  • cancer
  • cardiac dysfunction
  • cardio-oncology
  • artificial intelligence
  • machine learning
  • adverse events
03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's planned enrollment of 60 is below the median of 200 across 1,983 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Medical College of Wisconsin is the lead sponsor of 548 studies on the registry; 122 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 57 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Cancer survivors at intermediate, high, or very high risk for developing cardiovascular disease will pursue a cardio-oncology visit.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients ≥18 years with a history of cancer.
  2. Have not previously visited a cardiologist to assess cardiovascular risk after cancer diagnosis.
  3. Clinically at intermediate, high, or very high risk for cardiovascular diseases determined based on imprecise clinical risk models, such as those used for cardiac dysfunction.
  4. Ability to understand a written form, and willing to sign it prior to study registration.

Exclusion criteria

Exclusion Criteria:

  1. Patient \<18 years.
  2. Without a personal history of cancer.
  3. Existing cardiomyopathy diagnosed after cancer diagnosis.
  4. Documented cognitive impairment.
  5. Patient or patient representative who is unable and unwilling to sign the form.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Clinical Decision Aid Group

    In this group, physicians will use standard care plus the clinical decision aid.

    Other: Clinical Decision Aid

  • Control Group

    In this group, physicians will use standard care only.

    Other: Standard Care

Interventions

  • OtherClinical Decision Aid

    The clinical decision aid tool will be used at the subject's first visit (Week 0), Week 12 and Week 24.

  • OtherStandard Care

    Cardiology clinic visits will take place at the subjects first visit (Week 0), Week 12 and Week 24.

06

What researchers measure

Primary outcomes

  1. Medication use

    The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.

    Time frame: Week 0

  2. Medication use

    The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.

    Time frame: Week 12

  3. Medication use

    The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.

    Time frame: Week 24

  4. Imaging surveillance

    The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.

    Time frame: Week 0

  5. Imaging surveillance

    The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.

    Time frame: Week 12

  6. Imaging surveillance

    The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.

    Time frame: Week 24

07

Study locations

1 site
08

References and documents

Publications

  • Brown SA, Chung BY, Doshi K, Hamid A, Pederson E, Maddula R, Hanna A, Choudhuri I, Sparapani R, Bagheri Mohamadi Pour M, Zhang J, Kothari AN, Collier P, Caraballo P, Noseworthy P, Arruda-Olson A; Cardio-Oncology Artificial Intelligence Informatics and Precision Equity (CAIPE) Research Team Investigators. Patient similarity and other artificial intelligence machine learning algorithms in clinical decision aid for shared decision-making in the Prevention of Cardiovascular Toxicity (PACT): a feasibility trial design. Cardiooncology. 2023 Jan 23;9(1):7. doi: 10.1186/s40959-022-00151-0. PubMed 36691060 ↗
  • Brown SA, Fang MZ, Sparapani R, Zhou Y, Osinski K, Taylor B, Yu D, Blessing J, Shah R, Collier P, BagheriMohamadiPour M, Zhang J, Kothari A, Echefu G, Rickards J, Otto C, Sanchez Z, Olson J, Arruda-Olson A, Cheng YC, Cheng F; Cardio-Oncology Artificial Intelligence Informatics and Precision Equity, and Patient Similarity Algorithms in the Prevention of Cardiovascular Toxicity Research Team Investigators. PrevCardioOncAI: Machine Learning Algorithms for Predicting Cardiovascular Disease in Cancer Survivors. J Am Heart Assoc. 2025 Dec 16;14(24):e030363. doi: 10.1161/JAHA.123.030363. Epub 2025 Dec 11. PubMed 41378455 ↗
  • Brown SA, Hamid A, Pederson E, Bs AH, Maddula R, Goodman R, Lamberg M, Caraballo P, Noseworthy P, Lukan O, Echefu G, Berman G, Choudhuri I; Cardio-Oncology Artificial Intelligence Informatics & Precision Equity (CAIPE) and Patient Similarity Algorithms in the Prevention of Cardiovascular Toxicity (PACT) Research Team Investigators. Simplified rules-based tool to facilitate the application of up-to-date management recommendations in cardio-oncology. Cardiooncology. 2023 Oct 27;9(1):37. doi: 10.1186/s40959-023-00179-w. PubMed 37891699 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Start date
Dec 2026→Dec 2027
Nov 3, 2026
Primary completion
Dec 2027→Dec 2028
Nov 3, 2026
Study completion
Dec 2028→Dec 2029
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Start date Dec 2026→Dec 2027
    Primary completion Dec 2027→Dec 2028
    Study completion Dec 2028→Dec 2029
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05377320
Responsible party
Yee Chung Cheng (Associate Professor, Medical College of Wisconsin) — Principal investigator
First posted
May 17, 2022
Start date
Dec 2027 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2029 (estimated)
Last update
Nov 3, 2026

Study contacts

Yee Chung Cheng, MD
Contact
ycheng@mcw.edu
414-805-4600
Yee Chung Cheng, MD
principal investigator · Medical College of Wisconsin

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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