Myocardial InfarctionPhase 3NCT00269425
The Heart Institute of Spokane Diet Study
A Phase 3 study testing American Heart Association Step 2 diet and Mediterranean diet in people with Myocardial Infarction, run by Providence Health & Services at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a Mediterranean style diet, enriched in monounsaturated and omega-3 fats, is superior to the American Heart Association Step 2 diet, a traditional low fat diet, for improving rates of survival and cardiovascular complications in persons who have had a first myocardial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- American Heart Association Step 2 diet and Mediterranean diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Jan 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First myocardial infarction
Who cannot join
- Prior myocardial infarction
- Uncontrolled or secondary hypertension
- New York Heart Association heart failure stage III or IV
- Ventricular arrythmias requiring medical or defibrillatory intervention
- Other diseases that may make study completion difficult or unlikely
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Medical Research Center
Spokane, Washington, 99204
About this study
Official title: The Heart Institute of Spokane Diet Intervention and Evaluation Trial (THIS DIET)
The purpose of this study is to determine whether a Mediterranean style diet, enriched in monounsaturated and omega-3 fats, is superior to the American Heart Association Step 2 diet, a traditional low fat diet, for improving rates of survival and cardiovascular complications in persons who have had a first myocardial infarction (heart attack).
Read the detailed description
Cardiovascular diseases (heart attack, stroke, and other vascular diseases) are major causes of mortality in developed countries. Although medicines and revascularization procedures prolong lives, rates of death and disability remain high. Lifestyle factors greatly contribute to risk. Yet, scientific data regarding the role of lifestyle change in prevention and treatment are limited. In the nutrition area, limitations include observational or uncontrolled study design, and focus on surrogate markers rather than on clinical outcomes.
Excess dietary fat has long been associated with cardiovascular diseases. Increased risk is related both to types of fat and calories from fat. Saturated fat, cholesterol, and trans-fatty acids have all been associated with adverse outcomes. Because fat is calorie-laden, high fat diets are commonly associated with weight gain and obesity. Low-fat diets have traditionally been recommended to control lipids and weight. However, these diets are high in carbohydrate and may actually be associated with weight gain if calories are not limited. Such diets have also been associated with worsening of hyperinsulinemia and insulin resistance and an adverse lipid pattern (low HDL cholesterol and high triglyceride levels). In contrast, increased intake of monounsaturated and omega-3 fats is associated with favorable effects on cardiovascular risk factors and markers including: endothelial function, lipids, and levels of insulin and glucose. Results have been consistent across various groups of high-risk patients, including those with hypercholesterolemia, diabetes, and hypertension. Most importantly, a Mediterranean style diet enriched in monounsaturated and omega-3 fats reduced death and cardiovascular complications after myocardial infarction (MI) in the Lyon Heart study.
The American Heart Association (AHA) Step 2 is a low-fat diet traditionally recommended for people with cardiovascular disease. The Mediterranean and AHA Step 2 diets differ primarily in the amount of monounsaturated and omega-3 fats, both of which are higher in the Mediterranean diet. Both diets are low in saturated fat (less than 7%) and cholesterol (less than 200 mg/d). Although the Lyon Heart Study compared a Mediterranean diet to a "prudent Western diet," a low fat diet similar to the AHA diet, the latter group did not achieve recommended intake levels of saturated fat or cholesterol. Furthermore, there was no longitudinal nutritional intervention in the low fat diet group. Therefore, the effect of nutritional intervention per se was not addressed.
Comparison(s): In survivors of a first MI, two longitudinal nutritional interventions, a Mediterranean style diet and an AHA Step 2 diet, will be compared. Both intervention groups will be compared to an untreated control group from our clinical database.
- Conditions
- Myocardial Infarction
- Being tested
- American Heart Association Step 2 diet, Mediterranean diet
- Keywords
- Cardiovascular disease, Nutrition, Mediterranean diet, Low fat diet, American Heart Association diet, Monounsaturated fats, Omega-3 fats, Outcomes
- Medical subject headings
- Myocardial Infarction, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
American Heart Association Step 2 dietBehavioural
Also called Low fat diet
Low fat diet with patient education and diet analysis
Mediterranean dietBehavioural
Mediterranean style diet with patient education and diet analysis
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean diet, | Experimental | Not described Receives: Behavioral: Mediterranean diet |
| American Heart Association Step 2 diet | Experimental | Not described Receives: Behavioral: American Heart Association Step 2 diet |
| Case controlled | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatal/non-fatal myocardial infarction
The primary outcome was a composite of end points including all-cause and cardiac deaths, MI, hospital admissions for heart failure, unstable angina, or stroke.
Measured: 3,6,12,18,24,36,48,60,72 months
Cardiovascular death
Measured: 3,6,12,18,24,36,48,60,72 months
Non-cardiovascular death
Measured: 3,6,12,18,24,36,48,60,72 months
Stroke/TIA
Measured: 3,6,12,18,24,36,48,60,72 months
Admission for congestive heart failure or unstable angina
Measured: 3,6,12,18,24,36,48,60,72 months
Secondary outcomes (6)
Cardiovascular revascularization
Measured: 3,6,12,18,24,36,48,60,72 months
Peripheral revascularization or amputation
Measured: 3,6,12,18,24,36,48,60,72 months
Doubling of serum creatinine,dialysis,or kidney transplant
Measured: 3,6,12,18,24,36,48,60,72 months
New hypertension
Measured: 3,6,12,18,24,36,48,60,72 months
New diabetes
Measured: 3,6,12,18,24,36,48,60,72 months
Risk factors (traditional and novel)
Measured: 3,6,12,18,24,36,48,60,72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startOct 2000
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- The Heart Institute of Spokane, Providence Medical Research Center, Washington State Attorney General's Office, Deaconess Medical Center, Spokane, Washington
- Investigators
- Katherine R. Tuttle, MD,FASN,FACP, Principal investigator, Providence Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269425
- Sponsor's protocol ID
- THIS-A20010724157261
- Status last verified
- Dec 2005
- First submitted
- 22 Dec 2005
- Last updated
- 24 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Heart Institute of Spokane Diet Intervention and Evaluation Trial (THIS DIET)
- ClinicalTrials.gov ID
- NCT00269425
- Acronym / sponsor ID
- THIS-A20010724157261
- Conditions
- Myocardial Infarction
- Keywords
- Cardiovascular disease, Nutrition, Mediterranean diet, Low fat diet, American Heart Association diet, Monounsaturated fats, Omega-3 fats, Outcomes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- The Heart Institute of Spokane, Providence Medical Research Center, Washington State Attorney General's Office, Deaconess Medical Center, Spokane, Washington
- Study start
- Oct 2000
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 23 Dec 2005 (estimated)
- 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.
The purpose of this study is to determine whether a Mediterranean style diet, enriched in monounsaturated and omega-3 fats, is superior to the American Heart Association Step 2 diet, a traditional low fat diet, for improving rates of survival and cardiovascular complications in persons who have had a first myocardial infarction (heart attack).
Detailed description
Cardiovascular diseases (heart attack, stroke, and other vascular diseases) are major causes of mortality in developed countries. Although medicines and revascularization procedures prolong lives, rates of death and disability remain high. Lifestyle factors greatly contribute to risk. Yet, scientific data regarding the role of lifestyle change in prevention and treatment are limited. In the nutrition area, limitations include observational or uncontrolled study design, and focus on surrogate markers rather than on clinical outcomes.
Excess dietary fat has long been associated with cardiovascular diseases. Increased risk is related both to types of fat and calories from fat. Saturated fat, cholesterol, and trans-fatty acids have all been associated with adverse outcomes. Because fat is calorie-laden, high fat diets are commonly associated with weight gain and obesity. Low-fat diets have traditionally been recommended to control lipids and weight. However, these diets are high in carbohydrate and may actually be associated with weight gain if calories are not limited. Such diets have also been associated with worsening of hyperinsulinemia and insulin resistance and an adverse lipid pattern (low HDL cholesterol and high triglyceride levels). In contrast, increased intake of monounsaturated and omega-3 fats is associated with favorable effects on cardiovascular risk factors and markers including: endothelial function, lipids, and levels of insulin and glucose. Results have been consistent across various groups of high-risk patients, including those with hypercholesterolemia, diabetes, and hypertension. Most importantly, a Mediterranean style diet enriched in monounsaturated and omega-3 fats reduced death and cardiovascular complications after myocardial infarction (MI) in the Lyon Heart study.
The American Heart Association (AHA) Step 2 is a low-fat diet traditionally recommended for people with cardiovascular disease. The Mediterranean and AHA Step 2 diets differ primarily in the amount of monounsaturated and omega-3 fats, both of which are higher in the Mediterranean diet. Both diets are low in saturated fat (less than 7%) and cholesterol (less than 200 mg/d). Although the Lyon Heart Study compared a Mediterranean diet to a "prudent Western diet," a low fat diet similar to the AHA diet, the latter group did not achieve recommended intake levels of saturated fat or cholesterol. Furthermore, there was no longitudinal nutritional intervention in the low fat diet group. Therefore, the effect of nutritional intervention per se was not addressed.
Comparison(s): In survivors of a first MI, two longitudinal nutritional interventions, a Mediterranean style diet and an AHA Step 2 diet, will be compared. Both intervention groups will be compared to an untreated control group from our clinical database.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mediterranean diet, | Experimental | Behavioral: Mediterranean diet |
| American Heart Association Step 2 diet | Experimental | Behavioral: American Heart Association Step 2 diet |
| Case controlled | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First myocardial infarction
Key exclusion criteria (5 listed)
- Prior myocardial infarction
- Uncontrolled or secondary hypertension
- New York Heart Association heart failure stage III or IV
- Ventricular arrythmias requiring medical or defibrillatory intervention
- Other diseases that may make study completion difficult or unlikely
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 |
|---|---|---|
| American Heart Association Step 2 dietAlso: Low fat dietLow fat diet with patient education and diet analysis | Behavioural | American Heart Association Step 2 diet |
| Mediterranean dietMediterranean style diet with patient education and diet analysis | Behavioural | Mediterranean diet, |
Primary outcome
Fatal/non-fatal myocardial infarction
Time frame: 3,6,12,18,24,36,48,60,72 months
The primary outcome was a composite of end points including all-cause and cardiac deaths, MI, hospital admissions for heart failure, unstable angina, or stroke.
Cardiovascular death
Time frame: 3,6,12,18,24,36,48,60,72 months
Non-cardiovascular death
Time frame: 3,6,12,18,24,36,48,60,72 months
Stroke/TIA
Time frame: 3,6,12,18,24,36,48,60,72 months
Admission for congestive heart failure or unstable angina
Time frame: 3,6,12,18,24,36,48,60,72 months
6 secondary outcomes
Cardiovascular revascularization
Time frame: 3,6,12,18,24,36,48,60,72 months
Peripheral revascularization or amputation
Time frame: 3,6,12,18,24,36,48,60,72 months
Doubling of serum creatinine,dialysis,or kidney transplant
Time frame: 3,6,12,18,24,36,48,60,72 months
New hypertension
Time frame: 3,6,12,18,24,36,48,60,72 months
New diabetes
Time frame: 3,6,12,18,24,36,48,60,72 months
Risk factors (traditional and novel)
Time frame: 3,6,12,18,24,36,48,60,72 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2010.
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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. This study is not recruiting at the moment.
Katherine R. Tuttle, MD,FASN,FACP principal investigator
Providence Medical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing American Heart Association Step 2 diet and Mediterranean diet in people with Myocardial Infarction, run by Providence Health & Services 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 1 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: finished, as of the sponsor's last update on 24 Aug 2010. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatal/non-fatal myocardial infarction (time frame: 3,6,12,18,24,36,48,60,72 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2010.