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 2027to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (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.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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 2026
- First submitted
- 29 Apr 2022
- Last updated
- 3 Nov 2026
- 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
- ClinicalTrials.gov ID
- NCT05377320
- Acronym / sponsor ID
- PRO00039290
- Conditions
- Heart Failure, Coronary Artery Disease, Peripheral Artery Disease, Ischemia, Hypertension, Diabetes Mellitus
- Keywords
- clinical decision aid, cancer, cardiac dysfunction, cardio-oncology, artificial intelligence, machine learning, adverse events
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Dec 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Decision Aid Group | – | Other: Clinical Decision AidIn this group, physicians will use standard care plus the clinical decision aid. |
| Control Group | – | Other: Standard CareIn this group, physicians will use standard care only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cancer survivors at intermediate, high, or very high risk for developing cardiovascular disease will pursue a cardio-oncology visit.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Decision AidThe clinical decision aid tool will be used at the subject's first visit (Week 0), Week 12 and Week 24. | Other | Clinical Decision Aid Group |
| Standard CareCardiology clinic visits will take place at the subjects first visit (Week 0), Week 12 and Week 24. | Other | Control Group |
Primary outcome
Medication use
Time frame: Week 0
The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.
Medication use
Time frame: Week 12
The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.
Medication use
Time frame: Week 24
The number of subjects in which medication use pursued is consistent with current medical society recommendations appropriate for the subject.
Imaging surveillance
Time frame: Week 0
The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.
Imaging surveillance
Time frame: Week 12
The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.
Imaging surveillance
Time frame: Week 24
The number of subjects in which imaging surveillance pursued is consistent with current medical society recommendations appropriate for the subject.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 36691060Brown 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.
- Derived from this study: PubMed 41378455Brown 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.
- Derived from this study: PubMed 37891699Brown 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yee Chung Cheng, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Coronary Artery Disease, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yee Chung Cheng, MD (414-805-4600, ycheng@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication use (time frame: Week 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05377320, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.