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MACRO-I for Cardiovascular Disease (MACRO Trial)
N/A
Waitlist Available
Led By Daniel E Forman
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥70 year
Eligible cardiovascular disease (CVD) diagnosis (hospitalization for acute myocardial infarction/ acute coronary syndrome, stable ischemic heart disease, revascularization (coronary artery bypass graft surgery and percutaneous coronary intervention, valvular heart disease (surgical or transcatheter replacements or repair for mitral regurgitation or aortic stenosis),heart failure (exacerbation or new diagnosis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-, 6-, and 12-month change
Awards & highlights
MACRO Trial Summary
This trial is designed to help older adults with a cardiac event by providing coaching to help them recover their function.
Who is the study for?
This trial is for older adults aged 70 or above who have had a cardiovascular disease event and can participate in the study's activities. They must speak English and be able to give informed consent. People with non-CVD conditions expected to be fatal within a year, severe cognitive impairment, or those unable to follow up by phone or in person are excluded.Check my eligibility
What is being tested?
The MACRO trial tests a new coaching model called MACRO-I against usual care for cardiac rehabilitation (CR) in older adults. It aims to improve CR use and functional recovery after CVD events by addressing aging-related issues through random assignment of participants.See study design
What are the potential side effects?
Since this trial focuses on rehabilitation methods rather than medication, side effects may not apply as they would with drug trials. However, any potential discomfort from increased physical activity or psychological stress from lifestyle changes could occur.
MACRO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 70 years old or older.
Select...
I have been hospitalized or treated for a serious heart condition.
Select...
I speak English.
MACRO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-, 6-, and 12-month change
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-, 6-, and 12-month change
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
X-Ray Computed Tomography
AM-PAC-CAT - Daily Activity Domain
Accelerometry
+6 moreMACRO Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MACRO-IExperimental Treatment1 Intervention
A coaching intervention that supplements usual care.
Group II: Usual CareActive Control1 Intervention
Care after an acute heart event will be at the discretion of the participants' clinical providers.
Find a Location
Who is running the clinical trial?
Washington University School of MedicineOTHER
1,933 Previous Clinical Trials
2,299,351 Total Patients Enrolled
University of PittsburghLead Sponsor
1,719 Previous Clinical Trials
16,341,967 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,689 Total Patients Enrolled
2 Trials studying Cardiac Rehabilitation
176 Patients Enrolled for Cardiac Rehabilitation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe cognitive impairment.I am 70 years old or older.I have been hospitalized or treated for a serious heart condition.I speak English.I am able to participate in all study activities.I do not have a non-heart related condition expected to be fatal within a year.My health is stable without any recent serious issues.I live in long-term care and won't return to living on my own.I cannot attend follow-up assessments in person or by phone.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: MACRO-I
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any new participants being accepted for this trial at the moment?
"As per the information available on clinicaltrials.gov, this research is currently in search of participants. It was initially made visible to the public on November 4th 2019 and has been recently updated as of October 13th 2022."
Answered by AI
What is the enrollment size for this investigation?
"That's affirmative. Clinicaltrials.gov clarifies that this medical trial, which was initially made available on November 4th 2019, is actively seeking participants. Approximately 374 volunteers need to be recruited from 3 different clinical locations."
Answered by AI
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