Heart FailureNCT05377320
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
An observational study of Heart Failure and Coronary Artery Disease, run by Medical College of Wisconsin at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Coronary Artery Disease, Peripheral Artery Disease
- What is being tested?
- Clinical Decision Aid
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Cancer survivors at intermediate, high, or very high risk for developing cardiovascular disease will pursue a cardio-oncology visit.
Who may be able to join
- Patients ≥18 years with a history of cancer.
- Have not previously visited a cardiologist to assess cardiovascular risk after cancer diagnosis.
- 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.
- Ability to understand a written informed consent form, and willing to sign it prior to study registration.
Who cannot join
- Patient <18 years.
- Without a personal history of cancer.
- Existing cardiomyopathy diagnosed after cancer diagnosis.
- Documented cognitive impairment.
- Patient or patient representative who is unable and unwilling to sign the informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Yee Chung Chen, MD
About this study
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.
- Conditions
- Heart Failure, Coronary Artery Disease, Peripheral Artery Disease, Ischemia, Hypertension, Diabetes Mellitus
- Being tested
- Clinical Decision Aid, Standard Care
- Keywords
- clinical decision aid, cancer, cardiac dysfunction, cardio-oncology, artificial intelligence, machine learning, adverse events
- Medical subject headings
- Heart Failure, Coronary Artery Disease, Peripheral Arterial Disease, Ischemia, Hypertension, Diabetes Mellitus, Cardiomyopathies, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision AidOther
The clinical decision aid tool will be used at the subject's first visit (Week 0), Week 12 and Week 24.
Standard CareOther
Cardiology clinic visits will take place at the subjects first visit (Week 0), Week 12 and Week 24.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Decision Aid Group | In this group, physicians will use standard care plus the clinical decision aid. Receives: Other: Clinical Decision Aid | |
| Control Group | In this group, physicians will use standard care only. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication use
The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.
Measured: Week 0
Medication use
The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.
Measured: Week 12
Medication use
The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.
Measured: Week 24
Imaging surveillance
The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.
Measured: Week 0
Imaging surveillance
The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.
Measured: Week 12
Imaging surveillance
The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yee Chung Cheng, Medical College of Wisconsin
- Investigators
- Yee Chung Cheng, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377320
- Sponsor's protocol ID
- PRO00039290
- Status last verified
- Oct 2025
- First submitted
- 29 Apr 2022
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 36691060Brown 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 41378455Brown 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