NCT00269425

Brief 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 infarction (heart attack).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

August 24, 2010

Status Verified

December 1, 2005

Enrollment Period

7.3 years

First QC Date

December 22, 2005

Last Update Submit

August 23, 2010

Conditions

Myocardial Infarction

Keywords

Cardiovascular diseaseNutritionMediterranean dietLow fat dietAmerican Heart Association dietMonounsaturated fatsOmega-3 fatsOutcomes

Outcome Measures

Primary Outcomes (5)

  • 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.

    3,6,12,18,24,36,48,60,72 months

  • Cardiovascular death

    3,6,12,18,24,36,48,60,72 months

  • Non-cardiovascular death

    3,6,12,18,24,36,48,60,72 months

  • Stroke/TIA

    3,6,12,18,24,36,48,60,72 months

  • Admission for congestive heart failure or unstable angina

    3,6,12,18,24,36,48,60,72 months

Secondary Outcomes (6)

  • Cardiovascular revascularization

    3,6,12,18,24,36,48,60,72 months

  • Peripheral revascularization or amputation

    3,6,12,18,24,36,48,60,72 months

  • Doubling of serum creatinine,dialysis,or kidney transplant

    3,6,12,18,24,36,48,60,72 months

  • New hypertension

    3,6,12,18,24,36,48,60,72 months

  • New diabetes

    3,6,12,18,24,36,48,60,72 months

  • +1 more secondary outcomes

Study Arms (3)

Mediterranean diet,

EXPERIMENTAL
Behavioral: Mediterranean diet

American Heart Association Step 2 diet

EXPERIMENTAL
Behavioral: American Heart Association Step 2 diet

Case controlled

NO INTERVENTION

Interventions

American Heart Association Step 2 dietBEHAVIORAL

Low fat diet with patient education and diet analysis

Also known as: Low fat diet
American Heart Association Step 2 diet
Mediterranean dietBEHAVIORAL

Mediterranean style diet with patient education and diet analysis

Mediterranean diet,

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First myocardial infarction

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence Medical Research Center

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Myocardial InfarctionCardiovascular Diseases

Interventions

Diet, Fat-RestrictedDiet, Mediterranean

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDiet, Plant-Based

Study Officials

  • Katherine R. Tuttle, MD,FASN,FACP

    Providence Medical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2005

First Posted

December 23, 2005

Study Start

October 1, 2000

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

August 24, 2010

Record last verified: 2005-12

Locations

US(1)